BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNOSTREAM20

    MDR report key: 2860546 · Received December 4, 2012

    Report

    Report Number
    8044004-2012-00003
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    September 11, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ORIDION MEDICAL 1987 LTD.
    Product Code
    DQA
    PMA / PMN Number
    K082268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED AT MERCURY SERVICE CENTER, WHERE IT WAS DETERMINED THAT THE FAULT WAS IN THE AC-DC COMPONENT. THAT COMPONENT WAS RETURNED TO THE MANUFACTURER ON (B)(4) FOR ADDITIONAL INVESTIGATION AND WAS FOUND TO BE FAULTY. THE MANUFACTURER STUDIED THE CASE AND COLLECTED MORE INFORMATION FROM THE CUSTOMER, AND DETERMINED ON (B)(4) THAT THE EVENT REQUIRES AN MDR.

    Description of Event or Problem · 1

    THE DEVICE (A CAPNOGRAPH/PULSE OXIMETER) TURNED OFF WHILE IN USE ON A PT. THIS WAS NOTICED BY A RESPIRATORY THERAPIST AND ANOTHER DEVICE WAS SUBSTITUTED. NO PT HARM WAS CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNOSTREAM20 DQA ORIDION MEDICAL 1987 LTD. CS08751 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR