BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT 73X PORTABLE VENTILATOR SYSTEM

    MDR report key: 4232202 · Received November 6, 2014

    Report

    Report Number
    2242630-2014-00008
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    October 16, 2014
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K051476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SYSTEM WAS SHIPPED IN 2010 AND DID NOT RECEIVE PERIODIC MAINTENANCE BY THE MANUFACTURER AS RECOMMENDED.

    Description of Event or Problem · 1

    ((B)(4)) THIS SYSTEM WAS RETURNED TO THE MANUFACTURE FOR NORMAL PREVENTIVE MAINTENANCE AND REPAIR. CUSTOMER STATED THAT HIS UNIT WOULD NO LONGER TAKE A CHARGE. AFTER RECEIPT OF THIS SYSTEM, IT WAS DETERMINED THAT THE BATTERY, LEAD ACID TYPE, HAD LEAKED AND CAUSED THE UNIT TO BE UNREPAIRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713370 IMPACT 73X PORTABLE VENTILATOR SYSTEM VENTILATOR BTL IMPACT INSTRUMENTATION, INC. 73X NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED BY THE OPERATOR