BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7200AE MICROPROCESSOR VENTILATOR

    MDR report key: 268073 · Received March 10, 2000

    Report

    Report Number
    2024500-2000-00034
    Event Type
    Malfunction
    Date Received
    March 10, 2000
    Report Date
    March 9, 2000
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED, A 7200 AE VENTILATOR WAS BEING USED IN AN AMBULANCE. AFTER BEING PLUGGED INTO THE AMBULANCE INVERTER, THE INVERTER STARTED SMOKING. IT WAS REPORTED THAT FLAMES WERE SEEN FOR A FEW SECONDS IN THE AREA OF THE VENTILATOR'S UTILITY PANEL. THERE WERE NO INJURIES AS A RESULT OF THE INCIDENT. THE MFR'S CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND THAT THE MOV (METAL OXIDE VARISTOR) OPENED AND HAD BURN MARKS. THERE WERE NO OTHER SIGNS OF DAMAGE INDICATING A FIRE. THERE WERE NO SMOKE MARKS, FLAME MARKS, OR BRITTLE DISCOLORED WIRE. THE CSE REPLACED THE UTILITY PANEL. OTHER PARTS WERE REPLACED AS REQUESTED BY THE CUSTOMER AS A PRECAUTION DUE TO THE REPORTED NATURE OF THE INCIDENT. AGE AND WEAR WERE OTHER FACTORS FOR REPLACEMENT. THE UNIT PASSED EXTENDED SELF TESTING. IT IS NOT VERIFIED THAT THE VENTILATOR MALFUNCTIONED AND NO MALFUNCTION MAY HAVE OCCURRED. THE MOV IS DESIGNED TO PROTECT THE DEVICE IN A HIGH CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7200AE MICROPROCESSOR VENTILATOR VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT 7200AE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN