BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCAN

    MDR report key: 7448771 · Received April 20, 2018

    Report

    Report Number
    1220984-2018-00097
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 16, 2018
    Report Date
    March 23, 2018
    Manufacturer
    HOLOGIC, INC
    Product Code
    OXO
    PMA / PMN Number
    K120388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNINTERRUPTED POWER SUPPLY WAS RETURNED FOR EVALUATION. THE INVESTIGATION CONCLUDED THAT EMBRITTLEMENT OF THE PLASTIC BATTERY CASE IS LIKELY THE RESULT OF OVERCHARGING, WHICH RESULTS IN ELEVATED TEMPERATURES. ELEVATED TEMPERATURES CAN DIMINISH BATTERY LIFE. THE OPTIMUM OPERATING TEMPERATURE FOR THE LEAD-ACID BATTERY IS 25°C (77°F). AS A GUIDELINE FOR LEAD-ACID BATTERIES, EVERY 8°C (15°F) RISE IN TEMPERATURE CUTS THE BATTERY LIFE IN HALF. DIMINISHMENT OF THE CHARGE CAPACITY MAY LEAD TO OVERCHARGING. WHEN OVERCHARGING OCCURS HEAT IS GENERATED WHICH MAY ACCELERATE THE EMBRITTLEMENT OF THE PLASTIC HOUSING. THE CRACKING OF THE BATTERY HOUSING APPEARS TO HAVE LED TO THE SHORT-CIRCUIT CONDITION. THE SHORT-CIRCUIT CONDITION APPEARS TO HAVE LED TO THE SMELL OF SMOKE AS REPORTED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    AS OF TODAY THE INVESTIGATION REGARDING THIS ISSUE IS STILL IN-PROCESS. WE ARE AWAITING THE RETURN OF THE PART FOR EVALUATION. A FOLLOW-UP WILL BE FILED AS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY INSIDE THE PC POWER SUPPLY BURNED AND DAMAGED THE POWER SUPPLY CAUSING A SMELL OF SMOKE. NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS NEEDED. THE POWER SUPPLY WAS REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291346 FLUOROSCAN IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO HOLOGIC, INC INSIGHT 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1