BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR1 FLEXRACK, PS16B, NEO IP

    MDR report key: 23534045 · Received November 12, 2025

    Report

    Report Number
    9610617-2025-02063
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Report Date
    March 26, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    LMD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: POSSIBLE CAUSES: THERMAL OR ELECTRICAL STRESS WITHIN THE UPS BATTERY DURING/AFTER THE HOSPITAL'S MONTHLY GENERATOR TEST, LEADING TO INTERNAL BATTERY FAILURE AND EXPANSION. UPS FAILURE CAUSED BY BATTERY SWELLING/BLOATING, WHICH IS CONSISTENT WITH OVERCURRENT, OVER-TEMPERATURE, OR END-OF-LIFE CHEMICAL INSTABILITY IN SEALED BATTERIES. CONTRIBUTING FACTORS: UPS WAS RACK-MOUNTED IN AN ENCLOSED SPACE, WHICH MAY INCREASE HEAT EXPOSURE. BATTERY LIKELY CROSSING THE END OF SERVICE LIFE SINCE THE UNIT IS MORE THAN 2 YEARS OLD. LACK OF PLANNING OR PREVENTIVE MAINTENANCE SCHEDULE OR END-OF-LIFE TRACKING FOR UPS BATTERIES FROM CUSTOMER END. THE ISSUE WAS RESOLVED BY REPLACING DEFECTIVE RACK MOUNT UPS WITH A BRAND NEW POWERVAR UPS UNIT (WUIS3519) AND BY VERIFYING FULL FUNCTIONALITY. NO FURTHER ISSUES NOTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, THEY WILL SEND A SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION "L2 KFKOR002 - L2 DUE TO BURNING SMELL IN THE ROOM. KFK ROOM 2 - CUSTOMER SMELLED A BURNING SMELL IN THE ROOM AND SAYS IT'S COMING FROM THE AMX CONTROLLER." THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593760 OR1 FLEXRACK, PS16B, NEO IP OR1 FLEXRACK, PS16B, NEO IP LMD KARL STORZ SE & CO. KG WUIS3818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown