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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 Power Problem (3010)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The power management board will be returned to the national repair center (nrc) for further evaluation. A supplemental report will be provided.
 
Event Description
It was reported by the customer that the cardiosave intra-aortic pump is not recognizing ac power when plugged in. It is unknown the circumstances in which the event occurred or if there was patient involvement. However, there was no adverse event reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue, the batteries were depleted and not charging. The fse found the power management board to be faulty and replaced it to resolve the issue. The fse verified proper operation of the unit and battery charge and performed full preventative maintenance(pm). The iabp passed all calibration, functional, and safety checks to factory specifications. The unit was returned to the customer and cleared for clinical use. 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 found physical damage to q27. The technician then installed the power management board into cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it failed testing. The national repair center verify the reported failure "batteries do not charge while connected to ac power when pump console is in the cart. ". The power management board was being sent to the supplier per procedure. A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported by the customer that the cardiosave intra-aortic pump is not recognizing ac power when plugged in. It is unknown the circumstances in which the event occurred or if there was patient involvement. However, there was no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10017317
MDR Text Key189651467
Report Number2249723-2020-00695
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
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No

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