BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120V AUTOCAT IAB PUMP

    MDR report key: 1052551 · Received May 22, 2008

    Report

    Report Number
    1219856-2008-00242
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K983866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: FIELD SVC - FINDINGS/ACTIONS TAKEN: BIOMED COULD NOT DUPLICATE THE PROBLEM. COMPRESSOR REPLACED WITH THE THEORY IT PROBABLY WAS HOT FROM HOURS OF USE AND WOULD NOT RESTART. SVC WAS PERFORMED BY HOSP BIOMED.

    Description of Event or Problem · 1

    FIELD SVC REPORTS THE FOLLOWING: WHILE ON PT, UNRECOVERABLE LOW VACUUM ALARM ISSUED WHEN PUMP WAS PUT INTO ASSIST MODE, AFTER BEING TEMPORARILY PUT INTO STANDBY MODE TO FLUSH A LINE. THE PUMP WAS EXCHANGED OFF THE PT. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 120V AUTOCAT IAB PUMP INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK