BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 5869434 · Received August 11, 2016

    Report

    Report Number
    2031702-2016-00842
    Event Type
    Malfunction
    Date Received
    August 11, 2016
    Date of Event
    April 1, 2015
    Report Date
    November 15, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). CAREFUSION CERTIFIED SERVICE TECHNICIAN WAS UNABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. VISUAL INSPECTION REVEALED PIN 3 OF CABLE WAS BENT. VISUAL INSPECTION ALSO REVEALED POWER FLEX IS DAMAGED, PIN 5 OF JPF WAS BURNED. THE SERVICE TECHNICIAN REPLACED POWER FLEX AND UNIT PASSED ALL TESTING.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT INTENDED TO BE LEFT BLANK BUT BECOMES AUTO POPULATED AFTER SUBMISSION, AS A RESULT OF A SOFTWARE RELATED ANOMALY THAT IS BEING ADDRESSED. PLEASE DISREGARD THE DATE ENTERED. 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

    THE CUSTOMER REPORTED MODEL PALMTOP VENTILATOR REVEL PIGTAIL IS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521501 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC PTV

    Patients

    Seq Age Sex Outcome Treatment
    1