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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformance's related to the reported event were noted.A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm stated that the battery charge cycle would cut off after approximately 20 seconds.To address the issue the stm replaced the power management board; however the original battery in the iabp would still not accept charge.The stm replaced both batteries and tested.The stm performed a all calibration, all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that during a routine check the batteries on the cardiosave intra-aortic balloon pump (iabp) did not appear to be charging unit, the iabp shuts off.There was no patient involvement, thus no adverse event was reported.
 
Event Description
It was reported that during a routine check the batteries on the cardiosave intra-aortic balloon pump (iabp) did not appear to be charging unit, the iabp shuts off.There was no patient involvement, thus no adverse event was reported.
 
Manufacturer Narrative
The suspected faulty power management board was sent to getinge's national repair center (nrc) for evaluation.A senior repair technician inspected the power management board and no visual damage was observed.The technician then installed the power management board into cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it passed testing.The national repair center was able to charge two batteries with no problem observed.The power management board is being sent to the supplier per procedure.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during a routine check the batteries on the cardiosave intra-aortic balloon pump (iabp) did not appear to be charging unit, the iabp shuts off.There was no patient involvement, thus no adverse event was reported.
 
Event Description
It was reported that during a routine check the batteries on the cardiosave intra-aortic balloon pump (iabp) did not appear to be charging unit, the iabp shuts off.There was no patient involvement, thus no adverse event was reported.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h10.The supplier returned the power management board to the national repair center (nrc).The supplier could not verify the failure of the cardiosave not charging batteries.The supplier stated no problem was found and the board passed testing.A senior repair technician inspected the power management board and no visual damage was observed.The technician then installed the power management board into the cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it passed testing.The board will be packaged and labeled and sent to stock per procedure.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key9536232
MDR Text Key190339083
Report Number2249723-2019-02128
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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