BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANACEA 1500

    MDR report key: 3587826 · Received October 8, 2013

    Report

    Report Number
    1931947-2013-00003
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 17, 2013
    Report Date
    October 8, 2013
    Manufacturer
    NOA MEDICAL INDUSTRIES INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL 57 CONTROL BOXES WERE REPLACED AND THE OLD UNITS ARE BEING RETURNED TO NOA AS A PREVENTIVE MEASURE. THIS IS NOT BEING CONSIDERED A RECALL AT THIS MONUMENT AS NOA IS WAITING ON TEST RESULTS. WE HAVE (B)(4) OF THIS SERIAL NUMBER ONE DAYS PRODUCTION. WE DO NOT KNOW AT THIS TIME IF THE CONTROL BOX IS FAULTY. FULL FAILURE ANALYSIS OF CONTROL BOX IS BEYOND THE CAPABILITIES OF NOA. NOA DID PERFORM A BASIC INSPECTION. MAINS CABLE AND TRANSFORMER WERE TESTED FOR DIELECTRIC BREAK DOWN. FUSES WERE CHECKED. TOROID TRANSFORMER WAS IN PERFECT CONDITION. BATTERIES FOR BATTERY BACKUP LOOKED GOOD. PROBLEM WITH FACILITY WIRING WAS RULED OUT. SOURCE OF OVER HEATING WAS NOT IDENTIFIED. THE CONTROL BOX WAS SENT TO THE MANUFACTURER, (B)(4), FOR FAILURE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROL BOX OVER HEATED BUT DID NOT BURN THROUGH. THERE WERE NO INJURIES. THE CONTROL BOX WAS DEFORMED FROM HEAT. THE POWER CORD WAS IN GOOD CONDITION. SHOWED NO SIGN OF HEAT. THE CIRCUIT BREAKERS DID NOT TRIP AND INTERNAL FUSES DID NOT BLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510000 PANACEA 1500 AC POWERED ELECTRICAL HOSPITAL BED FNL NOA MEDICAL INDUSTRIES INC 1070000BEB

    Patients

    Seq Age Sex Outcome Treatment
    1