BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY

    MDR report key: 5284548 · Received December 10, 2015

    Report

    Report Number
    3010293992-2015-00221
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 15, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A COSTUMER FROM USA: "RETURNED TO BIO-MED FROM ICU. NOT EXPLANATION AS TO HOW IT BROKE OR WHAT WAS GOING ON. DELAY IN THERAPY: NO NEED FOR MEDICAL INTERVENTION: NO PATIENT INVOLVEMENT: NO DEATH / SERIOUS INJURY: NO HUMAN HARM: NO". AFTER RE-EVALUATED BEFORE CLOSING, THE EVENT MARKED AS REPORTABLE ON (B)(6), 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814603 POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1