BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6101087 · Received November 14, 2016

    Report

    Report Number
    2031702-2016-01418
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    April 7, 2014
    Report Date
    November 14, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS INCLUDED IN A TWO-YEAR RETROSPECTIVE COMPLAINT REVIEW TO ASSESS MDR REPORTABILITY COMPLIANCE. THIS COMPLAINT WAS DEEMED TO MEET THE REQUIREMENTS FOR MDR SUBMISSION AND IS THEREFORE BEING SUBMITTED TO THE FDA. (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FACTORY SERVICE DEPARTMENT RECEIVED THE SUSPECT COMPONENT AND WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. VISUAL INSPECTION REVEALS POWER FLEX CONNECTOR HAS DAMAGED PINS. PINS 2,3,4, AND 5 ARE BURNED. THE SUSPECT DEVICE WAS SCRAPPED AND A REPLACEMENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS DAMAGE TO THE DC INPUT CONNECTION OF THE AC ADAPTERS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749951 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AC POWER ADAPTER

    Patients

    Seq Age Sex Outcome Treatment
    1