BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR KIT

    MDR report key: 3960334 · Received June 23, 2014

    Report

    Report Number
    8010042-2014-00265
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXCHANGED PART HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE REPORTED COMPRESSOR ISSUE HAS BEEN FINALIZED. THE COMPRESSOR UNIT WAS INVESTIGATED BY MAQUET SERVICE TECHNICIAN. THE REPORTED ISSUE REGARDING THE COMPRESSOR GOING INTO STANDBY WAS REPRODUCIBLE DURING TESTING. THE COMPRESSOR STANDBY VALVE WAS REPLACED, THE UNIT PASSED ALL TESTS AFTER THE EXCHANGE OF THE STANDBY VALVE. THE COMPRESSOR UNIT WAS THEN RETURNED BACK TO SERVICE AT THE HOSPITAL. THE ELECTRICAL EVALUATION OF THE RETURNED STANDBY VALVE DID NOT SHOW ANY DEVIATIONS, NO OPEN CIRCUITS COULD BE ESTABLISHED. THE EVALUATION OF THE RETURNED VENTILATOR LOGS BELONG TO THE VENTILATOR THAT THE COMPRESSOR WAS CONNECTED TO CONFIRMS THE STANDBY ISSUE. WHEN THE COMPRESSOR GOES INTO STANDBY MODE, THE VENTILATOR WILL GENERATE ALARMS FOR LOW AIR GAS PRESSURE, AND HIGH O2 CONCENTRATION SINCE THE VENTILATOR DEVICE ONLY CONTINUES OPERATION WITH OXYGEN GAS. BOTH ALARMS WERE GENERATED AT THE REPORTED DATE OF EVENT. THE CAUSE FOR THE REPORTED EVENT WAS DUE TO THE FAULTY STANDBY VALVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR KEPT GOING INTO STANDBY, FAILING TO SUPPLY THE VENTILATOR WITH COMPRESSED AIR. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366078 COMPRESSOR KIT BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1