BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLETTE 8000

    MDR report key: 13023270 · Received December 16, 2021

    Report

    Report Number
    2510954-2021-00004
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    August 21, 2021
    Report Date
    December 16, 2021
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K001242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED NOTING THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR EVALUATION AND VIDEO IMAGING. THE DEPRESSION FRACTURE AND SUBDUAL HEMATOMA WERE CONFIRMED. THE BABY WAS DISCHARGED THE FOLLOWING DAY. THE HOSPITAL WAS TO DO A FOLLOW UP APPOINT IN A MONTH. PATIENT SEEMS TO BE RECOVERING. THE FOLLOWING FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. THE NURSE WENT TO CHECK AND FEED THE BABY. SHE OPENED BOTH PORT HOLES AND PUT ARMS IN TO FEED THE BABY, BED WAS FLAT. SHE HAND RAISED THE BABY TO FEED. THE NURSE DID STATE THAT SHE BELIEVES SHE CLOSED THE PORT HOLE DOOR, HOWEVER WHEN THE BABY WAS FOUND THE RIGHT PORT HOLD DOOR WAS OPEN AND THE BABY WAS FOUND BETWEEN THE WALL AND THE I8000 ON THE FLOOR. THE I8000 WAS EVALUATED ON SITE BY THE HOSPITAL BIOMED, THE HEAD OF CLINICAL ENGINEERING AND THE RISK MANAGER. THE LATCHES WERE TESTED AND PUSHED AND PULLED ON TO CONFIRM THEY LATCH PROPERLY AND WERE NOT WEAKENED. THE SITE INVESTIGATION IDENTIFIED ROOT CAUSE AS HUMAN ERROR AND CONFIRMED THAT THE UNIT DID NOT PLAY A FACTOR IN THE PATIENT OUTCOME. THERE WAS NO DRAEGER DEVICE MALFUNCTION. THE INSTRUCTIONS FOR USE INCLUDES AN OPERATIONAL CHECKOUT SECTION WHICH INCLUDES A HOOD/SHELL OPERATIONAL CHECKOUT PROCEDURE THAT INSTRUCTS THE USER TO CHECK THE HAND PORT LATCHES FOR PROPER OPERATION BY ¿PRESSING THE LATCH ON EACH HAND PORT AND VERIFY THAT DOOR SWINGS OPEN¿, AND ¿CLOSE THE DOORS AND CHECK FOR PROPER LATCHING AND QUIETNESS.¿ WARNING - RISK OF DEATH OR SERIOUS INJURY. POSITIVELY SECURE ALL HAND PORT LATCHES AND ACCESS PANEL LOCKING KNOBS TO AVOID ACCIDENTAL OPENING. WARNING - RISK OF DEATH OR SERIOUS INJURY. FOR INFANT SAFETY, DO NOT LEAVE THE INFANT UNATTENDED WHEN THE ACCESS PANELS OR HAND PORTS ARE OPEN. NOTE THAT THIS CASE WAS INITIALLY REPORTED UNDER MDR# 1220063-2021-00028 IN ERROR, THE CORRECT MDR# IS 2510954-2021-00004.

    Description of Event or Problem · 0

    DRÄGER WAS NOTIFIED THROUGH A MEDWATCH REPORT RECEIVED WHERE IS WAS REPORTED THAT A PATIENT HAD FALLEN OUT OF AN ISOLETTE 8000 AND SUSTAINED A HEAD DEPRESSION FRACTURE AND SUBDURAL HEMATOMA. ADDITIONALLY THE UNIT WAS INSPECTED BY THE BIOMEDICAL DEPARTMENT AND CONFIRMED THAT THE DOOR LATCHING MECHANISMS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921252 ISOLETTE 8000 INFANT INCUBATOR WITH OXYGEN, SCALE AND HUMDITY FMZ DRAEGER MEDICAL INFANT CARE, INC. MU21124

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Female Required Intervention