Notice to Hospitals - Safety information and corrective action on Air-Shields Isolette C2000/C2000e Infant Incubator

Starting date:

November 17, 2006

Posting date:

November 27, 2006

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001295

This is duplicated text of a letter from Draeger Medical Canada Inc.

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

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Airshields Isolette Infant Incubator C2000

November 17, 2006

From: Draeger Medical Canada Inc. - Regulatory Department

IF YOU HAVE ALREADY RESPONDED TO PREVIOUS NOTICES PLEASE DISREGARD THIS COMMUNICATION

Please distribute to Department of Biomedical and Clinical Engineering, NICU and other professional staff and post this notice in your institution.

Subject: Modification of Air-Shields^® Isolette^® C2000/C2000e Infant Incubator controller if display screen blanking occurs

Dear valued Customer,

Draeger Medical Canada has initiated a recall in accordance with the Canadian Medical Device Regulations of the Air-Shields^® Isolette^® C2000/C2000e Infant Incubator, Model: C2HS (-X), manufactured on or after May 1st 2002.

Some Controllers may experience intermittent or permanent display screen blanking associated with partial disconnects at U11 on the CPU Board and/or the 50-conductor cable connecting the interface and CPU Boards.

The clinical effect of display loss is variable. If the screen blanking is intermittent, there may be no effect at all, or the device may reset and run as intended, or the unit may fail to reset and an alarm indicating system failure will notify the caregiver. In each case that we have investigated, the device provides an audible alarm when this failure occurs. There has been no serious patient injury related to this device failure.

We recommend the following:

• Notify the appropriate staff that the display may unexpectedly go blank
• If the problem occurs, remove the affected unit from service and contact the Draeger service representative
• Make sure you have spare incubators available should you need to power off the affected incubator

We would like to inform you that the "display blanking" issue in the Air-Shields^® Isolette^® C2000/C2000e Infant Incubator has been solved and the solutions are announced below.

Beginning the 1st week of April 2006, each C2000 has been manufactured using an improved controller (identified as serial number RA23802 or higher), that eliminates the display blanking issue. Only C2000's in the field that experience this failure need to be upgraded. We have a field modification kit defined (part number MU18355) for these C2000's.

Please follow these 2 important steps:

1. Please complete the attached Customer Reply Form as soon as possible, if you have not sent one in already. Regardless of whether or not you have affected inventory and/or have experienced this failure, regulatory requirements necessitate the completion of the Customer Reply Form and faxing it to our Regulatory Affairs Dept. at: fax 1-905-763-1890.
2. If you do have affected product(s) and have experienced the failure, make sure to point this out on the Customer Reply Form. Your Draeger Representative will contact you to arrange a service event or the provision of the modification kit.

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-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents for medical devices in patients using Draeger Medical products should be reported to Draeger Medical Canada or Health Canada at the following addresses:

Draeger Medical Canada Inc.

120 East Beaver Creek Rd, Suite 104

Richmond Hill, Ontario

L4B 4V1

Telephone: 1-866 343 2273

Fax: 905-763-1890

www.draeger-medical.ca

Any suspected adverse incident can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

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

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

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

Marketed Health Products Directorate (MHPD)

MHPD_DPSC@hc-sc.gc.ca

Tel: (613) 954-6522

Fax: (613) 952-7738

Thank you very much for your understanding and cooperation.

Sincerely,

original signed by

Andreas Mueller

Director of Quality and Regulatory Affairs

Customer Reply Form

To: Andreas Mueller

Departement: Quality and Regulatory Affairs

Company: Draeger Medical Canada Inc.

Fax: 905.763.1890

Phone.: 1(866)343-2273, 905.763.3702

Subject: Airshields Isolette C2000 Display blanking

(PLEASE FILL IN BELOW)

Customer:

Telephone:

Email:

Address:

Address Line 2:

City:

Province:

(PLEASE FILL IN BELOW)

I, ____________ have received and understand the recall information.

  (PLEASE PRINT)

Title:

Signature:

Date:

(PLEASE FILL IN BELOW)

We have Draeger Medical / Airshields products: Yes  No

Serial numbers of:

Incubators:

Jaundice Meters:

Open Warmers:

Phototherapy Lights:

Ventilators:

We have experienced above mentioned failure: Yes  No

DMS PQ2020 A52, RI01, effective date: 2006-11-06