BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY (FIXED HEADS )ASM

    MDR report key: 5672314 · Received May 23, 2016

    Report

    Report Number
    3010293992-2016-00133
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 25, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR INFORMATION: (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER, SAN JOSE, CA 95138. EXEMPTION NUMBER: E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "SN: (B)(4). POWER SUPPLY SEPARATED AT WALL RECEPTACLE LEAVING PRONGS PLUGGED INTO WALL AND EXPOSING WIRES AND CIRCUIT BOARD INSIDE BRICK ASSEMBLY. NURSE RECEIVED SHOCK WHEN REMOVING PLUG FROM WALL RECEPTACLE. COVER FOR WALL PLUG CAME APART AND NURSE CONTACTED WIRES STILL CONNECTED TO 120 VOLTS AC. SHOCK TRAVELLED UP NURSES ARM. UNIT REMOVED FROM USE. TYPE OF DRUG: NA. DELAY IN THERAPY: UNKNOWN. NEED FOR MEDICAL INTERVENTION: UNKNOWN. PATIENT INVOLVEMENT: YES. DEATH / SERIOUS INJURY: NO. HUMAN HARM: NO." ADDITIONAL INFORMATION WAS RECEIVED ON MAY 05, 2016: "NO SERIOUS INJURY/DEATH OCCURRED AS A RESULT OF THE INCIDENT. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. THE POWER SUPPLY CATALOGUE NUMBER IS 15072-000-0005 4. THE LOT NUMBER IS 0915I ORDERED SOME REPLACEMENT POWER SUPPLIES AND THE CATALOGUE NUMBER ON THESE IS 15072-000-0007. THERE ARE SOME DIFFERENCES."

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM CANADA: DISASSEMBLY OF POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328190 POWER SUPPLY (FIXED HEADS )ASM POWER SUPPLY MRZ Q CORE MEDICAL LTD. 0915

    Patients

    Seq Age Sex Outcome Treatment
    1