BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLETTE INFANT INCUBATOR

    MDR report key: 99070 · Received June 13, 1997

    Report

    Report Number
    2510954-1997-00006
    Event Type
    Malfunction
    Date Received
    June 13, 1997
    Date of Event
    May 5, 1997
    Report Date
    June 13, 1997
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT AN OPTIONAL MONITOR SHELF HAD BECOME DETACHED FROM ITS MOUNTING POLE. A 4.35 KG (9.6 LBS.) MONITOR WAS ON THE SHELF AND FELL OFF. IT WAS REPORTED THAT AT THE TIME OF OCCURRENCE THE INCUBATOR WAS SET UP AWAITING THE ARRIVAL OF AN INFANT. THE REPORTED FAILURE MECHANISM WAS THAT THE THREAD INSERT INSIDE THE PLASTIC MONITOR SHELF HAD BECOME LOOSE AND SEPARATED FROM THE SHELF. NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLETTE INFANT INCUBATOR NEONATAL INCUBATOR FMZ AIR SHIELDS, INC. C2HS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA