BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENOVATE MEDICAL MOBIUS POWER

    MDR report key: 6181815 · Received December 15, 2016

    Report

    Report Number
    MW5066736
    Event Type
    Other
    Date Received
    December 15, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ENOVATE MEDICAL
    Product Code
    FCO
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, AT APPROX 0850AM, A WOW BATTERY, IN THE CHANGING BAY LOCATED IN AN IN-PATIENT STORAGE AREA FAILED, CAUSING A BATTERY DE-PASSION ISSUE. THIS FAILURE PRODUCED A NOXIOUS ELECTRICAL OVERHEATING ODOR, AND SOOT FROM THE FAILED BATTERY CELL ON THE BATTERY, AND ON THE CHARGER UNIT. TEAMS FROM ENGINEERING REPORTED TO THE LOCATION AND DETERMINED THE DANGER WAS CONTAINED, AND THE CODE RED COULD BE CANCELLED, WITHOUT THE (B)(6) FIRE DEPARTMENT RESPONDING TO THE EVENT. THE IT TEAM ALSO REPORTED TO THE LOCATION, REMOVED THE FAILED BATTERY, THE CHARGER, ALONG WITH 3 ADD'L BATTERIES THAT WERE IN THE CHARGER. THESE 3 BATTERIES DID NOT DISPLAY SIGNS OF DRAINAGE. THE RESULTING NOXIOUS ORDER RESULTED IN A RE-LOCATION OF PTS ON THAT WING, AND A STAFF MEMBER SUFFERED ASTHMA RELATED SYMPTOMS RESULTING IN THE NEED TO GO TO THE ED. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830098 ENOVATE MEDICAL MOBIUS POWER MOBIUS POWER IND. BATTERY 26AH FCO ENOVATE MEDICAL 3118313 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 BAY BATTERY CHARGING STATION: PART # 3116873