BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT INVACARE

    MDR report key: 3915576 · Received June 10, 2014

    Report

    Report Number
    9681154-2014-00011
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
    Product Code
    CAF
    PMA / PMN Number
    K042483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND UNABLE TO DETERMINE THE CONDITION OF THE INSULATION. THERE WAS NO PT HARM OR DEATH REPORTED IN THIS INSTANCE. WITH THE INFO PROVIDED, THIS INVESTIGATION REMAINS INCONCLUSIVE, NO FURTHER FOLLOW UP REPORTING WILL BE PROVIDED FOR THIS COMPLAINT UNLESS NEW INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A INVACARE COMPRESSOR HAS EXPOSED WIRING ON THE POWER CORD OF THE DEVICE. NO FURTHER INCIDENCE OCCURRED AND NO INJURY OR DEATH WAS REPORTED DURING THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337345 COMPACT INVACARE COMPRESSOR, AIR, PORTABLE CAF RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1