BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INCUBATOR

    MDR report key: 39616 · Received September 24, 1996

    Report

    Report Number
    MW1009976
    Event Type
    Malfunction
    Date Received
    September 24, 1996
    Date of Event
    September 13, 1996
    Report Date
    September 17, 1996
    Manufacturer
    AIR-SHIELDS, INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A FIVE DAY OLD ACTIVE INFANT WEIGHING 2050 GMS WAS PLACED IN AN INCUBATOR THROUGH THE FRONT ACCESS PANEL. THE ACCESS PANEL LATCHES WERE INADVERETENTLY NOT ENGAGED. SHORTLY THEREAFTER, THE INFANT KNOCKED OPEN THE ACCESS PANEL AND FELL TO THE FLOOR. SUBSEQUENT INVESTIGATION REVEALED TWO PROBLEMS. 1. THE STAFF DID NOT CHECK THE ACCESS PANEL DETENT OPERATION ON A REGULAR BASIS. 2. THE STRIKER PLATES ON THE ACCESS PANEL HAS NO ACCESS PANEL DETENT. IT IS UNKNOWN IF THE DETENT WOULD HAVE PREVENTED THIS INCIDENT. OF THE SEVEN UNITS IN THE FACILITY, FIVE HAD WORN STRIKER PLATES AND EFFECTIVELY NO ACCESS PANEL DETENT. THE INFANT WAS NOT INJURED IN THIS INCIDENT, BUT THE POSSIBILITY EXISTS FOR PT INJURY IN THIS TYPE OF INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY Other