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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); Retraction Problem (1536)
Patient Problem No Patient Involvement (2645)
Event Date 11/06/2018
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 company standard operating procedure since the device manufacture date is greater than one year from the event date.(b)(6).A supplemental report will be submitted when subsequent information is provided.
 
Event Description
It was reported that the external power supply pins were damaged on the cardiosave intra-aortic balloon pump (iabp), and that the wheels would not retract in the rescue unit.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and replaced the external power supply due to physical damage noted.In addition, the stm observed wear and tear on the base and cover of the iabp unit; the base wheel alignment bracket was out of alignment.To resolve this issue, the stm adjusted the bracket back into place, then cleaned and lubricated the axles.The stm then performed all calibration, functional and safety tests which passed to factory specifications, and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that the external power supply pins were damaged on the cardiosave intra-aortic balloon pump (iabp), and that the wheels would not retract in the rescue unit.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
MDR Report Key8112609
MDR Text Key128744303
Report Number2249723-2018-02077
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,user f
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
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 Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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