BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO ELITE

    MDR report key: 5004439 · Received August 12, 2015

    Report

    Report Number
    9681154-2015-00012
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 23, 2015
    Report Date
    November 17, 2015
    Manufacturer
    RESPIRATORY DRUG DELIVERY GROUP (UK) LTD.
    Product Code
    CAF
    PMA / PMN Number
    K063103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DESPITE NUMEROUS ATTEMPTS TO RETRIEVE THE DEVICE FOR INVESTIGATION, NO PRODUCT HAS BEEN RETURNED. THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGATION THE "POWER CORD HAS A SHORT WITH EXPOSED WIRES". RDD490 IS A DC COMPRESSOR THAT IS POWERED BY AN AC/DC POWER ADAPTOR. THE ONLY WIRE IN THIS DEVICE IS IN THE DC CIRCUIT OF THE POWER ADAPTOR WHICH WOULD POSE NO RISK TO THE INTENDED USER. INSTRUCTION FOR USE STATES:"NEVER OPERATE THIS PRODUCT IF IT HAS A DAMAGED CORD OR PLUG". BASED ON THE INFORMATION PROVIDED, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY. THE COMPRESSOR WAS MANUFACTURED IN JANUARY, 2013.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ON THE (B)(6) 2015 ALLEGING COMPRESSOR HAD NO POWER AND THAT THERE WERE EXPOSED WIRES. THERE WAS NO REPORTED HARM OR INJURY OT THE PATIENT. THE DEVICE HAS NOT BEEN RETURNED TO DATE TO ALLOW FURTHER INVESTIGATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530428 MICRO ELITE COMPRESSOR, AIR, PORTABLE CAF RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. RDD490 131

    Patients

    Seq Age Sex Outcome Treatment
    1