BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2830227 · Received November 13, 2012

    Report

    Report Number
    2031642-2012-00494
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    November 5, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SWITCH WAS REPLACED AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT TO UNKNOWN RESTART WHILE ON PATIENT. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE FHE REPORTED PROBLEM OR RESTART OCCURRENCE DURING TESTING. THE MANUFACTURER SERVICE TECH REPLACED THE POWER SWITCH AS A PRECAUTIONARY MEASURE. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1