|
Catalog Number IAP-0500 |
Device Problems
Device Alarm System (1012); Power Problem (3010)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/08/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) while in use, the staff experienced a system error #3 alarm and a high baseline alarm.As a result, the pump was switched out quickly.The pump was sent to biomed.The biomedical engineer found that the pins on the mforce motor driver were charred.The biomed replaced the driver.It was also noted by the staff that the pump would give "running on battery alarm" when the pump was jostled.The pump was sent to biomed, where the power supply was replaced.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex received the device for investigation.The reported complaint of system error 3 alarm is confirmed.The pump alarmed system error 3 during the functional test with the returned motor driver cable installed.Upon return, discoloration consistent with burn marks was noted on the connector and on the motor driver cable.The root cause of motor driver cable failure is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.A nonconformance has been initiated to further investigate the root cause.
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) while in use, the staff experienced a system error #3 alarm and a high baseline alarm.As a result, the pump was switched out quickly.The pump was sent to biomed.The biomedical engineer found that the pins on the mforce motor driver were charred.The biomed replaced the driver.It was also noted by the staff that the pump would give "running on battery alarm" when the pump was jostled.The pump was sent to biomed, where the power supply was replaced.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
|
|
Search Alerts/Recalls
|
|
|