BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN ADVANCE TABLE, 230V AC

    MDR report key: 19775071 · Received July 18, 2024

    Report

    Report Number
    3010216206-2024-00007
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON ON-SITE INSPECTION, BAXTER TECHNICIAN DETERMINED THAT POWER SWITCH AND SOCKET HAD SHORT CIRCUIT DUE TO WATER INGRESS. THE INTENDED USERS OF THE ALLEN® ADVANCE TABLE ARE HEALTHCARE EMPLOYEES WHO HAVE BEEN TRAINED TO USE THE PRODUCT, AND WHO HAVE THE PHYSICAL STRENGTH AND COGNITIVE SKILLS TO OPERATE AND CONTROL THE PRODUCT. FOLLOW FACILITY SAFETY PROTOCOLS IF AN INTENDED USER DOES NOT HAVE THE PHYSICAL STRENGTH OR COGNITIVE SKILLS TO OPERATE AND CONTROL THE PRODUCT SAFELY. TECHNICIAN REPLACED THE POWER SWITCH AND SOCKET. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A DAMAGED POWER SUPPLY WITH EXPOSED WIRES WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALLEN ADVANCE TABLE WAS SPARKING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555644 ALLEN ADVANCE TABLE, 230V AC TABLE, OPERATING-ROOM, ELECTRICAL GDC ALLEN MEDICAL SYSTEMS A-71101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown