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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.
 
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Brand NameCARDIOSAVE HYBRID 3.1 EDITION
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
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
Reporter Country CodeEI
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/20/2019
1 Device was Involved in the Event
0 Patients were 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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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