Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Patient Data Module (2014-08-27)

Starting date:
August 27, 2014
Posting date:
September 9, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41295

Recalled Products   

Patient Data Module 

Reason

The following issue is being addressed by GE Healthcare file no. FMI 36107: If the Patient Data Module (PDM) is quickly disconnected and reconnected (a less than 10 second cycle) from a CARESCAPE Bx50 Monitor following a "patient discharge" or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly. The ECG heart rate (HR) parameter data, the ECG waveform analysis and other ECG parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. As a result of the abnormal analysis of data, the alarms for serious conditions may not be triggered appropriately. The issue potentially affects heart rate, ECG ST segment analysis, 12 lead ECG analysis, ECG, SPO2, respiration and invasive blood pressure waveforms both locally and at CIC, and data displayed at CIC may show data drop out. Neither bedside nor CIC data can reliably represent the parameters being measured. If your facility uses the PDM only with Transport Pro or Solar Monitors the issue does not exist.

Affected products

Patient Data Module 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2042084-001-XXXXXXX

Companies
Manufacturer
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
53223
UNITED STATES