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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and verified that the upper screen displayed dark patches and screen to be unreadable.To address the issue, the fse replaced the display top lcd assembly.The fse ran the unit and it and passed all performance and functional tests.The iabp unit was to the customer for clinical use.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a monitor related issue in which the upper screen displayed static, dark blank spots and was unreadable.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, 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 Key8187775
MDR Text Key131340930
Report Number2249723-2018-02184
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/26/2018
Initial Date FDA Received12/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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