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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Device Emits Odor (1425); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) evaluated the iabp and replaced the solenoid driver board and the power management board to resolved the issue.The fse performed all calibration, functional and safety tests on iabp, which passed.The iabp was returned to customer and cleared for clinical use.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) shutdown, and there was also a burning smell.However, therapy was resumed with another cardiosave iabp and no adverse event was reported.
 
Manufacturer Narrative
The suspected defective solenoid driver board was returned to getinge's national repair center (nrc) for failure analysis.A technician inspected the board and observed visual damage to capacitor c11, and upon inspection of the board per procedure, the board was functionally equivalent to the current lowest usable revision of the released solenoid control board.In addition, the technician verified the failure of a burning smell.The burning smell was caused by capacitor c11 burning up.The technician was unable to install the board into the cardiosave test fixture to be tested.The nrc sent the board to the supplier for failure analysis per procedure.The supplier stated that the board was not repairable due to component c11 burning which caused the pad for the component to lift up.The root cause of the failure was the burnt capacitor c11.The nrc will be scrapping the board per procedure.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) shutdown, and there was also a burning smell.However, therapy was resumed with another cardiosave iabp and no adverse event was reported.
 
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Brand Name
CARDIOSAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7560838
MDR Text Key110181820
Report Number2249723-2018-00916
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
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received02/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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