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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Failure to Select Signal (1582); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 02/29/2020
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 field service engineer (fse) replaced the power management board to address the issue.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during a service/test on a cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse) that the iabp was unable to switch from battery drive to ac drive, the iabp could only switch from ac drive to battery drive.There was no patient involvement, thus no adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) reported that the iabp unit was cleared to be used clinically after all functional and safety checks to meet factory specifications were performed and passed.The defective power management board was requested to be sent to the national repair center for further evaluation.A supplemental report will be submitted upon completion of this evaluation.
 
Event Description
It was reported that during a service/test on a cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse) that the iabp was unable to switch from battery drive to ac drive, the iabp could only switch from ac drive to battery drive.There was no patient involvement, thus no adverse event was reported.
 
Manufacturer Narrative
The suspected faulty oob 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 the cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it passed testing.After numerous times of switching the unit from battery to ac and from ac to battery , there were no incidences of the unit failing.This test was performed inside the cart and also with the console outside of the cart.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 an incoming inspection on a brand new cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the iabp was unable to switch from battery drive to ac drive, the iabp could only switch from ac drive to battery drive.This is an out-of-box (oob) failure.There was no patient involvement, thus 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, and replaced component ic u16, then the board passed testing.A senior repair technician inspected the power management board and no visual damage was observed.The nrc 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 was packaged and labeled and sent to stock per procedure.
 
Event Description
It was reported that during an incoming inspection on a brand new cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the iabp was unable to switch from battery drive to ac drive, the iabp could only switch from ac drive to battery drive.This is an out-of-box (oob) failure.There was no patient involvement, thus no adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID INT 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 Key9871251
MDR Text Key190825056
Report Number2249723-2020-00473
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-65
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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