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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 Problems Break (1069); Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 09/07/2018
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.The getinge service territory manager (stm) disassembled and replaced the touchscreen, reassembled and tested the unit, but the problem was still present.The stm later returned to disassemble the iabp unit and replace the video generated board.The stm reassembled and tested the unit¿s touchscreen and it was now functional.The stm continued to disassemble the console to replace the broken fiber optic sensor extension.All functional and pm testing was completed and the iabp unit was cleared for clinical use.(b)(6).
 
Event Description
It was reported that during a preventative maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp), the getinge service territory manager (stm) discovered a faulty touchscreen and a broken fiber optic sensor connector.There was no patient involvement and no adverse event was reported.
 
Event Description
It was reported that during a preventative maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp), the getinge service territory manager (stm) discovered a faulty touchscreen and a broken fiber optic sensor connector.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
After further review, it was discovered that the follow-up 1 was reported incorrectly.The corrected (the date entered in block of the initial mdr was incorrect, and should have been reported as 06-sept-2018 as opposed to 07-sept-2018).
 
Event Description
It was reported that during a preventative maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp), the getinge service territory manager (stm) discovered a faulty touchscreen and a broken fiber optic sensor connector.There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
Corrected fields: the date entered of the initial mdr was incorrect, and should have been reported as 06-jan-2019 opposed to 07-jan-2019.
 
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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
MDR Report Key7923885
MDR Text Key122478239
Report Number2249723-2018-01695
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
Type of Report Initial,Followup,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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