DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
|
Back to Search Results |
|
Model Number 0998-00-0800-53 |
Device Problem
No Device Output (1435)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/27/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during preventive maintenance performed by a getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) unit's printer failed.There was no patient involvement.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Manufacturer Narrative
|
It was reported that cardiosave intra-aortic balloon pump (iabp) printer failed.A getinge field service engineer (fse) evaluated unit and confirmed corrosion seen on printer board components.Replaced printer.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.No patient involvement.The defective components were received for further investigation.The failure analysis and testing dept.Received part with a reported unit failure of the printer test.The fat performed a visual inspection and found the part to be in good condition.The fat installed the printer in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.This part failed to print anything during the printer test.Fat verified the reported failure.Retaining the part in the failure analysis and testing department per procedure number (b)(4) rev.Ap.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
|
|
Search Alerts/Recalls
|
|
|