BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6099435 · Received November 14, 2016

    Report

    Report Number
    2031702-2016-01387
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    June 5, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION WAS ABLE TO VERIFY THE REPORTED ISSUE. VISUAL INSPECTION REVEALED PIN# 2 OF THE LEMO CONNECTOR ON THE POWER FLEX WAS BURNT. CAREFUSION REPLACED THE POWER FLEX TO ADDRESS THE REPORTED ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT THE UNIT HAD A DAMAGING LEMO CONNECTOR AND A PIN FROM THE CHARGER MIGHT BE STUCK IN THE CONNECTOR. WHILE IN SERVICE, IT WAS DISCOVERED THAT THE UNIT HAD A BURNT PIN. THIS REPORTABLE ISSUE WAS DISCOVERED WHILE IN SERVICE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749900 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC REVEL

    Patients

    Seq Age Sex Outcome Treatment
    1