BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 3231863 · Received July 15, 2013

    Report

    Report Number
    2518422-2013-01426
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE SERVICE EVALUATION FOUND THAT THE BATTERY WAS UNABLE TO REACH FULL CHARGE CAPACITY DUE TO NORMAL WEAR ASSOCIATED WITH RECHARGEABLE BATTERIES. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THIS REPORT IS BEING SUBMITTED AS PART OF A PROGRAM TO RETROSPECTIVELY REVIEW POSSIBLE DEVICE MALFUNCTIONS THAT DID NOT INVOLVE ANY INJURY, TO DETERMINE WHETHER THEY ARE REPORTABLE UNDER 21 CFR PART 803 AND THE MANUFACTURER'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER 12-PHI-01.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING THE INTERNAL BATTERY WAS NOT LASTING AS LONG AS EXPECTED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327647 PLV-100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 35001

    Patients

    Seq Age Sex Outcome Treatment
    1