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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-31
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 06/19/2020
Event Type  malfunction  
Manufacturer Narrative
On december 14, 2020, clarification was received that the reported event is a reportable complaint.The fse replaced the power supply then completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The suspected faulty main board was returned to getinge's national repair center (nrc) for further evaluation.A getinge senior repair technician inspected the main board and no visual damage was observed.The technician installed the main board into the cs300 iabp test fixture and tested to factory specifications per the cs300 service manual.The main board failed testing and the reported failure was observed and electrical test failure code #4 was printed out of the recorder.The main board will be sent to the supplier for failure investigation per procedure.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the during installation of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the power supply would not function.The input voltage measured 230vac and the output voltage measured 0v.This is an out-of-box failure of the power supply.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h10.The cart bulk power supply was returned to the manufacturer for further evaluation.A senior repair technician of the national repair center (nrc) inspected board and no visual damage was observed.The technician installed the power supply into the cardiosave test fixture and tested the supply to factory specifications per the cardiosave service manual.The technician verified the failure of the power supply not functioning and observed 0v on the output voltage.The power supply failed testing.The power supply was sent to the supplier for failure analysis per procedure.The national repair center received the cart bulk power supply from the supplier.The power supply was sent to the supplier for failure analysis only.The supplier verified the failure of 0 volts output voltage.The supplier found two components mosfets q18 and q20 that had shorted.The supplier stated that exact root cause is unknown.A possible reason could be a.Component mortality or b.Back drive voltage- a voltage back driving the output stage that can cause the output to fail.The power supply will be retained in the national repair center per procedure.***please note*** this complaint was reported as an oob, however the supply was in trunk stock for approximately 2 years.
 
Event Description
It was reported that the during installation of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the power supply would not function.The input voltage measured 230vac and the output voltage measured 0v.This is an out-of-box failure of the power supply.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that the during installation of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the power supply would not function.The input voltage measured 230vac and the output voltage measured 0v.This is an out-of-box failure of the power supply.There was no patient involvement, and no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE I PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11165511
MDR Text Key226800164
Report Number2249723-2021-00062
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109053
UDI-Public10607567109053
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
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-0800-31
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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