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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 0998-00-0800-53
Device Problem Failure to Charge (1085)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and confirmed that the batteries were not charging properly while the unit was connected to the a/c power.To fix the issue, the fse replaced the power management pcb, and then performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.
 
Event Description
It was reported that during patient transport from the or to the icu, the cardiosave intra- aortic balloon pump (iabp) sounded and displayed a "low battery" alarm, and then unit shut down.In addition, it was reported that the patient was quickly connected to a different pump to continue therapy.There was no harm or injury to the patient and 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 visual damage was observed to component q27 which was shorted.Due to the shorting of q27, the national repair center was not able to test the power management board in the cardiosave test fixture.Past experience has proven that when q27 shorts, the batteries are not able to charge.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 patient transport from the or to the icu, the cardiosave intra- aortic balloon pump (iabp) sounded and displayed a "low battery" alarm, and then unit shut down.In addition, it was reported that the patient was quickly connected to a different pump to continue therapy.There was no harm or injury to the patient and no adverse event was reported.
 
Manufacturer Narrative
The supplier returned the power management board to the national repair center (nrc).The supplier verified the failure of the batteries not charging and replaced components q27 and q50 and installed cn167210.The board then passed testing.A senior repair technician inspected the power management board and no visual damage was observed.The installation of cn167210 was also verified.The national repair center installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure, and cardiosave service manual, and the board passed testing.The board was packaged and labeled and sent to stock per procedure.Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 12 month product complaint trend data for the period feb-2020 through jan-2021 was reviewed.There were no triggers identified for the review period.
 
Event Description
N/a.
 
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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 Key11261846
MDR Text Key230247102
Report Number2249723-2021-00180
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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,health
Type of Report Initial,Followup,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN.
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