BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 9084853 · Received September 18, 2019

    Report

    Report Number
    2249723-2019-01497
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 22, 2019
    Report Date
    November 8, 2019
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED FAULTY OOB COMPRESSOR WAS RETURNED TO GETINGE¿S NATIONAL REPAIR CENTER (NRC) FOR EVALUATION. A SENIOR REPAIR TECHNICIAN INSPECTED THE COMPRESSOR AND FOUND THE JACKET OF THE CABLE HARNESS COMING OUT OF THE MOTOR RIPPED OPEN WITH THE WIRES EXPOSED. THE SENIOR REPAIR TECHNICIAN ALSO FOUND BROKEN RED WIRE(MOTOR A) NICKED INSULATION WITH BARE WIRE SHOWING ON GREEN WIRE(HALL -) AND THE BROWN WIRE(HALL A). THE NATIONAL REPAIR CENTER VERIFIED THE REPORTED FAILURE OF "NEW COMPRESSOR WAS FOUND IN DAMAGED CONDITION WHEN THE BOX WAS OPENED". SCRAPPED AND RETAINING THE PUMP ASSEMBLY IN THE NRC PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CABLE OF A NEW COMPRESSOR WAS FOUND TO BE IN DAMAGED CONDITION WHEN THE BOX WAS OPENED BY A GETINGE REPRESENTATIVE. THIS IS AN OUT-OF-BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT; THUS NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A PRODUCTION DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED AS THIS COMPLAINT IS FOR AN OUT-OF-BOX PART FAILURE, AND THERE WAS NO ALLEGED MALFUNCTION OF AN INTRA-AORTIC BALLOON PUMP (IABP). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE OF A NEW COMPRESSOR WAS FOUND TO BE IN DAMAGED CONDITION WHEN THE BOX WAS OPENED BY A GETINGE REPRESENTATIVE. THIS IS AN OUT-OF-BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT; THUS NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876033 UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1