BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANACEA 1500

    MDR report key: 3456033 · Received September 23, 2013

    Report

    Report Number
    1931947-2013-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 7, 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

    FULL FAILURE ANALYSIS WAS 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) LINEAR MOTION TECH, FOR FAILURE ANALYSIS.

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED THAT THE CONTROL BOX CAUGHT FIRE, LATER IT WAS CLARIFIED THAT THERE WAS NO FLAME BUT THAT CONTROL BOX SMELLED LIKE A BATTERY. MAINTENANCE MAN THOUGHT IT MAY BE THE BATTERY THAT OVER HEATED. 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
    480260 PANACEA 1500 AC POWERED ELECTRICAL HOSPITAL BED FNL NOA MEDICAL INDUSTRIES, INC. 1070000BEB

    Patients

    Seq Age Sex Outcome Treatment
    1