BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4894792 · Received July 1, 2015

    Report

    Report Number
    3010293992-2015-00117
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 17, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "WE HAVE BEEN EXPERIENCING AN EXTENSIVE FAILURE RATE ON THE DOMESTIC VERSION OF SAPPHIRE EXTERNAL POWER SUPPLIES. IN PARTICULAR, THE PLASTIC SHELLS HOUSING THE ELECTRONICS EASILY SEPARATES (CREATING A SERIOUS ELECTRICAL SAFETY HAZARD). ALSO, THE CABLE IN THE LOW-VOLTAGE POWER PLUG SEPARATES WITH LITTLE EFFORT FROM THE CONNECTOR SHELL. AT (B)(6) ALONE, WE HAVE EXPERIENCED A FAILURE RATE OF 40% (20/50) SINCE GO-LIVE. UPON CLOSE EXAMINATION, THE POWER PACK SHELL DOES NOT HAVE AN ADEQUATE BONDING AGENT. IN OTHER DESIGNS, AN EPOXY IS USED TO FILL THE VOIDS, BOND COMPONENTS, AND TRANSMIT HEAT TO OUTER SURFACES. THE LOW-VOLTAGE POWER PLUG LACKS ADEQUATE FRICTION IN THE LOCKING RING ASSOCIATED WITH THE CONNECTOR SHELL. SOME OF THE FAILURES COULD BE ATTRIBUTED TO CARELESS USAGE. BUT WHEN COMPARED TO FAILURE RATES OF OTHER DEVICES HAVING EXTERNAL POWER PACKS, THE SAPPHIRE FAILURE RATE IS BEYOND ANYTHING WE HAVE SEEN BEFORE. DELAY IN THERAPY: UNK. NEED FOR MEDICAL INTERVENTION: UNK. HUMAN HARM: NO". ADDITIONAL INFO RECEIVED ON 06/23/2015: "PRIOR TO IMPLEMENTING THE SAPPHIRE INFUSION PUMPS THROUGHOUT (B)(6), THE PARTICULAR POWER SUPPLY IN QUESTION HAD NEVER BEEN USED BY US. ONE SITE ((B)(6) HOSPITAL) HAD RECEIVED THE SAPPHIRE PUMPS LAST YEAR WITH AN INTERNATIONAL VERSION OF THE POWER SUPPLY. THIS WAS PROBLEMATIC BECAUSE THE ELECTRICAL OUTLET ADAPTER WOULD EASILY POP OFF THE POWER SUPPLY. UP UNIT THE POINT WHERE THE POWER SUPPLY SHELL WOULD SEPARATE, THE POWER SUPPLY WOULD FUNCTION PROPERLY. AND UP TO THE POINT WHERE THE CABLE SEPARATED FROM THE LOW-VOLTAGE CONNECTOR SHELL, THE POWER SUPPLY FUNCTIONED PROPERLY. A CLOSE PHYSICAL INSPECTION OF THE POWER SUPPLY SHELL DOES NOT SHOW ANY SIGNS OF EXCESSIVE FORCE (DISTORTION, COMPRESSION, ETC.). THE SAME CAN BE SAID FOR THE LOW-VOLTAGE CONNECTOR SHELL, PINS, RETAINING RING AND CABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426338 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY 4814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK