BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADEL

    MDR report key: 84232 · Received April 11, 1997

    Report

    Report Number
    84232
    Event Type
    Death
    Date Received
    April 11, 1997
    Date of Event
    April 5, 1997
    Report Date
    April 9, 1997
    Manufacturer
    STRYKER
    Product Code
    HDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT, 17 WEEKS PREGNANT, ADMITTED WITH CRAMPING. DETERMINATION MADE THAT CERCLAGE NEEDED TO BE DONE. WHILE BEING MONITORED IN LABOR & DELIVERY SUITE, PT WAS IN BIRTHING BED. PT ATTEMPTED TO TURN ON LEFT SIDE. UTILIZED THE HEEL OF HER FOOT TO PUSH HERSELF UP IN THE BED. PUSHED AGAINST THE LOWER PART OF THE BED. BED CAME APART. LEFT CENTER CORNER FELL INWARD AND ENTIRE LOWER PART OF BED DISENGAGED AND FELL TO THE FLOOR. PT FELL TO THE FLOOR ON HER LEFT SIDE. NO HEALTH CARE PROVIDER IN THE ROOM AT THE TIME OF THE EVENT. HOWEVER, THE NOISE BROUGHT SEVERAL STAFF MEMBERS TO THE ROOM. ATTENDING PHYSICIAN WAS THE FIRST TO ARRIVE. PT WAS THEN KNEELING ON MATTRESS WHICH WAS ON THE LOWER PART OF THE BED WHICH WAS ON THE FLOOR. APPROX. 20 MINUTES LATER, PT HAD SPONTANEOUS RUPTURE OF MEMBRANES. DELIVERED LIVE FETUS WHICH HAD HEART BEAT FOR 20 MINUTES BEFORE IT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADEL BIRTHING BED HDD STRYKER 2100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 * Death