BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL-ROM AIR-SHIELDS PHOTOTHERAPY UNIT

    MDR report key: 257874 · Received January 6, 2000

    Report

    Report Number
    2510954-1999-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2000
    Date of Event
    June 11, 1999
    Report Date
    November 3, 1999
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IN 1999 A HILL-ROM AIR-SHIELDS SADDLE PHOTOTHERAPY UNIT (MODEL PTM78-2) WAS BEING USED IN CONJUNCTION WITH A HILL-ROM AIR-SHIELDS OVERHEAD WARMER (MODEL PM78-1). THE WARMER WAS BEING USED ON A NEONATE WITH AN OXYGEN TENT SURROUNDING THE INFANT. THE ATTENDING NURSE STATED THAT THE PHOTOTHERAPY UNIT HAD BEEN TURNED ON AND WAS RUNNING FOR APPROX 20 MINUTES BEFORE THE INCIDENT OCCURRED. THE NURSE SAID SHE SAW A HOT FRAGMENT ARC FROM THE TOP OF THE PHOTOTHERAPY UNIT OVER THE OVERHEAD WARMER AND LAND ONTO A CLOTH DIAPER SITTING ON A SHELF AT THE REAR OF THE WARMER. THE FRAGMENT BURNT A HOLE INTO THE CLOTH DIAPER BUT DID NOT IGNITE AN OPEN FLAME ON THE DIAPER. THE ATTENDING NURSE REMOVED THE PHOTOTHERAPY UNIT FROM SERVICE AND CONTACTED THE CLINICAL ENGINEERING DEPARTMENT WITHIN THE HOSPITAL. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HILL-ROM AIR-SHIELDS PHOTOTHERAPY UNIT PHOTOTHERAPY ATTACHMENT LBI HILL-ROM AIR-SHIELDS PTM78-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1