BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 2950284 · Received February 6, 2013

    Report

    Report Number
    8010042-2013-00012
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    September 27, 2012
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4), OUR FIELD SERVICE TECHNICIAN WAS ON SITE TO FURTHER INVESTIGATE THIS ISSUE AND IT WAS DETERMINED THAT THE DRAINAGE VALVE WAS NOT FUNCTIONING PROPERLY, NOT ALLOWING THE UNIT TO BUILD UP THE CORRECT PRESSURE. THE DRAINAGE VALVE WAS REPLACED. THE REPLACED PART HAS BEEN REQUESTED FOR INVESTIGATION BUT HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL MEDWATCH WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR ALARMED FOR "LOW PRESSURE". THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49640 COMPRESSOR MINI BTI MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA