Catalog Number 102954 |
Device Problems
Battery Problem (2885); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient demographics were requested but were not provided.Device unique identifier (udi) - device was manufactured prior to the udi labeling implementation.Approximate age of device - the centrimag primary console is not a single use device.Approximate age of the device from the ship date is 6 years, 8 months.The device was returned for investigation.The evaluation is not yet complete.A supplemental report will be submitted when the manufacturer's investigation is completed.
|
|
Event Description
|
The patient was being supported with an extracorporeal circulatory support device.It was reported that the primary console turned off when ambulating the patient.The console's battery reportedly died without any warning alarm that the battery was low.There was no reported adverse patient impact.Prior to the event, the console had remained plugged in until actual ambulation.The center's biomedical engineering department reported that the console ran less than 5 minutes on battery power.They confirmed that the battery was two or more years old.It was reported that the biomedical department plans to change out the batteries every 1.5 years to prevent future occurrences.Further information was requested but not provided.
|
|
Manufacturer Narrative
|
The report of the centrimag primary console being unable to operate on battery power and not alarming for a low battery could not be confirmed or reproduced through the evaluation of the returned centrimag primary console.The battery maintenance procedure was performed to evaluate battery run time, and the unit passed with no issues.It was reported that the centrimag primary console had a battery replacement after the incident occurred.The battery that was in the primary console at the time of the event was not returned for evaluation; however, it was reported that the battery was over two years old.A review of the device history records showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing its file on this event.
|
|
Search Alerts/Recalls
|