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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems No Device Output (1435); Failure to Sense (1559)
Patient Problem No Patient Involvement (2645)
Event Date 04/23/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) was dispatched to evaluate the iabp. The stm was able to verify the reported alarm in the iabp's diagnostic error log. This error is indicative of a fiber optic module issue and the alarm log showed the error was a three minute process. The stm removed all the boards in the pcb cage and reseated them. The stm then completed all diagnostic and performance tests and could not duplicate any issues. The stm ran the fiber optic test several times and could not duplicate the errors. All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) kept alarming "fos continuous bit failure" and that the printer was not printing. It is unknown under which circumstances this event occurred; however there was no patient involvement and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8621859
MDR Text Key145503845
Report Number2249723-2019-00825
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
Type of Report Initial,Followup
Report Date 06/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2019
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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