DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-3023-53 |
Device Problems
Premature Discharge of Battery (1057); Noise, Audible (3273)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/24/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that , the cs300 intra-aortic balloon pump (iabp) is making a rumbling sound, battery is not lasting, has a short battery life.There was no patient involvement.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
A getinge field service engineer (fse) evaluated the unit and troubleshot as per service manual and found no errors logs or faults logs found.During preliminary checks the fse found the iabp not passing battery run time test and heard no abnormal sounds.The fse stated that the rumbling noise heard might be from when unit shut off when batteries died.As per service manual the fse replaced batteries and completed all functional and safety tests per manufacturer specifications.The unit passed all tests performed and was returned to the customer and cleared for clinical use.
|
|
Search Alerts/Recalls
|
|
|