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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID 3.1 EDITION; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CARDIOSAVE HYBRID 3.1 EDITION; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440); Failure of Device to Self-Test (2937)
Patient Problem No Patient Involvement (2645)
Event Date 06/20/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit 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 getinge fse replaced the video generator board and performed all functional and safety test as per factory specifications.The iabp was then returned to the customer and cleared for clinical use.
 
Event Description
It was reported that.During a routine safety disk change, the getinge field service engineer (fse), entered service mode to update the replacement details and he found the touch screen to be massively out of calibration.The fse attempted to carry out a calibration of the touch screen and was unable.Upon restarting the machine in clinical mode to see what effect all this was having the iabp presented electrical test failure.The fse then ordered a new video generator board and it failed out of box.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
The customer returned the video generator board to getinge¿s national repair center (nrc) for evaluation.A senior repair technician evaluated the video generator board and no visual damage was observed.The senior repair technician then installed the video generator board into cardiosave test fixture and tested to factory specifications per cardiosave service manual.The nrc verified the error code #6.This code is a touchscreen configuration error code.The nrc calibrated the touchscreen.The error code was no longer observed upon startup of the cardiosave after the touchscreen was calibrated.The senior repair technician sent the part to supplier for failure analysis as per procedure.A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that during a routine safety disk change, the getinge field service engineer (fse), entered service mode to update the replacement details and he found the touch screen to be massively out of calibration of cardiosave intra-aortic balloon pump (iabp).The fse attempted to carry out a calibration of the touch screen and was unable.Upon restarting the machine in clinical mode to see what effect all this was having the iabp presented electrical test failure.The fse then ordered a new video generator board and it failed out of box.There was no patient involvement and no adverse event was reported.
 
Event Description
It was reported that during a routine safety disk change, the getinge field service engineer (fse), entered service mode to update the replacement details and he found the touch screen to be massively out of calibration of cardiosave intra-aortic balloon pump (iabp).The fse attempted to carry out a calibration of the touch screen and was unable.Upon restarting the machine in clinical mode to see what effect all this was having the iabp presented electrical test failure.The fse then ordered a new video generator board and it failed out of box.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
The national repair center (nrc) received the video generator board from the supplier.The supplier stated that no trouble found and the board passed testing.The senior repair technician of the nrc inspected the video generator board and no visual damage was observed.The technician installed the video generator board into cardiosave test fixture, tested to factory specifications per cardiosave service manual, and passed testing.The board will be returned to stock per procedure.
 
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Brand Name
CARDIOSAVE HYBRID 3.1 EDITION
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7884742
MDR Text Key120834225
Report Number2249723-2018-01614
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
Report Date 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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