Urgent Medical Device Correction - AED Plus Defibrillator: serial numbers below x _ _ _200000 - For Health Professionals

Starting date:

February 12, 2009

Posting date:

March 26, 2009

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information, Medical Devices

Audience:

Healthcare Professionals

Identification number:

RA-15925

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This is duplicated text of a letter from Medical Corporation Pharmaceutical.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on ZOLL AED Plus Defibrillator

February 12, 2009

Subject: ZOLL AED Plus Defibrillator May Not Deliver Therapy

Dear Health Care Professional,

We have received reports that following a long period (typically greater than four years) without use, a ZOLL® may prompt "change batteries" during use and fail to deliver therapy. Turning the device off completely, waiting ten seconds for the unit to re-set and then turning it back on is necessary to resume proper operation. Our investigation of this problem has determined that some batteries may develop high internal resistance that interferes with the batteries expected performance, lengthening charging time beyond specified and clinically acceptable limits.

ZOLL Medical Corporation is informing owners of all AED Plus devices with serial numbers below X_ _ _200000 to replace batteries that have been installed in devices for a period longer than three (3) years and at subsequent three (3) year intervals.

Required Corrective Actions

1. Determine the date batteries were installed in your device.
2. If batteries were installed more than three (3) years ago, replace the batteries as soon as possible and add the battery replacement label indicated in the Addendum to the ZOLL AED Plus Administrator's Guide showing the next scheduled replacement date. Read and incorporate the addendum information into the ZOLL AED Plus Administrator's Guide.
3. If batteries are not more than three (3) years old, add the label completed with the next scheduled replacement date. Read and incorporate the addendum information into the ZOLL AED Plus Administrator's Guide.

Units above serial number X_ _ _200000 are not affected by this corrective action as they contain software that can detect this battery condition and identify when batteries require replacement. In lieu of adding the battery replacement label users may obtain this new software for their AEDs at no cost at ZOLL AED Plus Battery Help.

Customer Assistance

ZOLL AED Plus Battery Help will be available on February 16th 2009 and will provide other technical information and support concerning this corrective action, such as help in determining battery age and ordering of replacement batteries and extra labels. We have arranged special pricing of $39.95 per set of ten batteries inclusive of shipping that can be ordered by credit card at this site. We are offering this special pricing for customers affected today as well as for future replacements to mitigate the cost associated with a shorter than expected battery life.

Health Canada has been notified of this corrective action and classified it as a Priority II recall.

We apologize for any inconvenience this may cause you and thank you in advance for assistance in implementing this corrective action. Avoiding this problem during clinical use is our highest priority. Our 24/7 technical support numbers 1 (800) 348-9011 or+1 (978) 421-9460 are available to assist users with any aspect of this notice.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious specific adverse incident or other serious or unexpected adverse incidents in patients using ZOLL AED Plus Defibrillator should be reported to ZOLL Medical or Health Canada at the following addresses:

ZOLL Medical Corporation

Worldwide Headquarters

269 Mill Road

Chelmsford, Massachusetts 01824-4105

Tel.: 1 (800) 348-9011 or +1 (978) 421-9460

Any suspected adverse reaction can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: MHPD_DSPC@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Paul Dias

VP Quality Assurance & Regulatory Affairs

Addendum to the ZOLL AED Plus Administrator's Guide

Applies to all units with SW version 5.18 and lower

Instructions for the Installation of New Batteries and Battery Replacement Label for the ZOLL AED Plus

Please Note: Replace the batteries in your AED Plus® three years from the installation date of new batteries.

1. Ensure that the AED Plus is turned off. Open the battery compartment by removing the battery cover from the back of the unit.
2. Remove all batteries at once and dispose of old batteries properly. Place new batteries into the battery bank, observing battery polarity markings and making sure that all batteries are securely seated and properly oriented. After placing the first 5 to 9 batteries in the battery well, the INSTALL BATTERIES audio prompt reminds you to install the remaining batteries in the battery compartment.
3. After installing new batteries, press the Battery Reset Button inside the battery compartment when prompted. Pressing the button resets the battery usage indicator to full charge.
4. Close the battery compartment.
5. Turn the AED Plus over.
6. Locate battery replacement label which is included in the battery kit.
7. Write the battery replacement date on label. (Three calendar years from today's date.) Example: If today's date is (03/22/2009) the replacement date will be (03/22/2012).
8. Peel label from paper.
9. Affix label onto AED Plus below the "Status Indicator", as displayed below.

Explanation of Symbols:

The Replace batteries before date should go at the right of the battery and hourglass symbol - Replace batteries before date

Place the AED Battery Replacement Label below the AED Plus Status Indicator

AED Battery Replacement Label located below the AED Plus Status Indicator

9652-0120-01, Rev A

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