BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLETTE INCUBATOR

    MDR report key: 204022 · Received December 23, 1998

    Report

    Report Number
    204022
    Event Type
    Malfunction
    Date Received
    December 23, 1998
    Date of Event
    November 10, 1998
    Report Date
    December 22, 1998
    Manufacturer
    HILL ROM AIR SHIELDS
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    LATCH ON PORT-HOLE DOOR ON INCUBATOR HOOD FAILED WHEN BABY PUSHED AGAINST IT. BABY FELL OUT OF ISOLETTE THROUGH PORT-HOLE TO THE FLOOR. NO INJURIES NOTED TO DATE. BIOMEDICAL TECHNICIAN INVESTIGATED EQUIPMENT. ACCESS DOOR GASKETS WERE IMPROPERLY INSTALLED AFTER WEEKLY CLEANING, WHICH CAUSED EXCESS WEAR TO DOOR LATCH ASSEMBLY. RECEIVED COPY OF ECRI HEALTH DEVICES MONTHLY JOURNAL SAME WEEK OF INCIDENT ON PAGE 370; HAZARD REPORT ARTICLE OF SIMILAR INCIDENT MENTIONED PROBLEM WAS DUE TO ACCESS DOOR GASKETS BEING INSTALLED IN REVERSE AND CAUSED THE DOOR NOT TO LATCH SECURELY; NOTIFIED HILL-ROM AIR-SHIELDS OF INCIDENT AND HAZARD REPORT BY ECRI. RPTR ASKED WHY FACILITY WAS NOT NOTIFIED OF POTENTIAL HAZARD, AS NEW EQUIPMENT AFTER 1/1997 INCORPORATED THE NEW DOOR GASKET DESIGN WHICH PREVENTS USER FROM IMPROPERLY INSTALLING THE GASKETS. MFR SAID A LETTER WAS NOT SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLETTE INCUBATOR INFANT INCUBATOR FMZ HILL ROM AIR SHIELDS C-100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other