BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHALASIA PNEUMATIC HAND PUMP AND MONITOR

    MDR report key: 1000797 · Received February 21, 2008

    Report

    Report Number
    3005099803-2008-00171
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBA
    PMA / PMN Number
    K781772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED, BUT AN EVAL IS NOT COMPLETE; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT UNK. ON JANUARY 22, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACHALASIA PNEUMATIC HAND PUMP AND MONITOR WAS TESTED PRIOR TO A PT'S PROCEDURE. ACCORDING TO THE COMPLAINANT, PRETESTING PERFORMED BY THE HOSP'S TECHNICAL DEPT. "THE PRESSURE IS 2 (TWICE) AS HIGH AS THE GAUGE SAYS. FOR EXAMPLE: WHEN THE UNITS SAYS THE PSI IS 10, IN REALITY THE PSI IS 20." THE CUSTOMER ELECTED TO NOT USE THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHALASIA PNEUMATIC HAND PUMP AND MONITOR GBA GBA BOSTON SCIENTIFIC CORPORATION M00553200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1