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

• Reason
• Affected products

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