BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA INFANT WARMER SYSTEMS

    MDR report key: 281353 · Received June 8, 2000

    Report

    Report Number
    1121732-2000-00004
    Event Type
    Malfunction
    Date Received
    June 8, 2000
    Date of Event
    May 7, 2000
    Report Date
    May 11, 2000
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE A PATIENT WAS BEING TREATED ON THE SUBJECT DEVICE, A NURSE OBSERVED SPARKS COMING FROM THE POWER CORD WHERE IT ATTACHES TO THE UNIT. THE UNIT WAS DISCONNECTED FROM THE WALL AND THE PATIENT WAS REMOVED FROM THE WARMER. THERE WAS NO INJURY. THE OHMEDA SERVICE REPRESENTATIVE EVALUATED THE EQUIPMENT AND FOUND THAT WHERE THE POWER CORD AND LINE FILTER INTERFACE, THERE WAS SMOKEY SOOT, THE CASING OF THE ON/OFF SWITCH HAD MELTED, AND THE SHIELDING AROUND THE AREA WAS BURNED. THE PART WAS RETURNED TO OHMEDA MEDICAL FOR FAILURE ANALYSIS. THE PART WAS DETERIORATED TO THE POINT THAT THE EXACT CAUSE OF THIS FAILURE COULD NOT BE ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA INFANT WARMER SYSTEMS INFANT RADIANT WARMER FMT OHMEDA MEDICAL IWS 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other