| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00945-1 |
| Product Name/Description |
Patient Data Module (PDM) Used with CARESCAPE Monitor B850, B650, or B450 (Multiparameter Patient Monitor)
All versions of PDM software v2.2 or lower
ARTG number: 92726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to ECG performance issues following a disconnect/reconnect cycle with the Patient Data Module (PDM), when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (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 analysed incorrectly and the alarms for serious conditions may not be triggered appropriately. 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. 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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To prevent the occurrence of the issues, when physically disconnecting the PDM from the CARESCAPETM Monitor Bx50 users should wait a minimum of 10 seconds before reconnecting. If users notice the ECG heart rate value appears to be half of the patient's physiologic condition or the patient waveforms (ECG, SpO2, Invasive Blood Pressure, or Impedance Respiration) appear to show every other pulse, follow these steps to correct the parameter and alarm issues:
1)Physically disconnect the PDM E-port cable or un-dock the PDM from the host monitor.
2)Wait a minimum of 10 seconds and then reconnect or re-dock the PDM.
When the PDM re-establishes communication with the Bx50, the parameters and alarms will operate as expected. GE Healthcare will also implement a permanent software fix.This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |