BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEMI-ELEC SNGLE CRANK HI/LO 9153638224

    MDR report key: 8209937 · Received January 2, 2019

    Report

    Report Number
    1031452-2019-00001
    Event Type
    Death
    Date Received
    January 2, 2019
    Date of Event
    November 26, 2018
    Report Date
    January 29, 2019
    Manufacturer
    INVACARE FLORIDA
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS FROM THE CORONER¿S OFFICE WERE RECEIVED, ENTRAPMENT WAS CONFIRMED. THE INVACARE LABEL ON THE HALF RAIL WAS VISIBLE BUT THE LOT NUMBER COULD NOT BE SEEN. DUE TO SHEETS ON THE BED THE MATTRESS WAS NOT VISIBLE BUT THE DEALER CONFIRMED IT WAS A DRIVE PRODUCT. IF MORE INFORMATION IS RECEIVED A FOLLOW-UP WILL BE FILED.

    Description of Event or Problem · 0

    MEDWATCH REPORT 141634-2018-0001, 141634-2018-0002, AND 141634-2018-0003 RECEIVED FROM VITAS HEALTHCARE STATING: "ON CALL RN RECEIVED A CALL STATING PATIENT HAD PASSED AND DAUGHTER WAS HYSTERICAL. WHEN OCRN ARRIVED AT THE HOME PT WAS DECEASED AND KNEELING ON THE LEFT SIDE OF THE BED WITH HER HEAD ENTRAPPED BETWEEN THE BED FRAME AND HALF SIDE RAIL.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION. THE DEALER ADVISED THAT A DRIVE 15006 DURAGUARD INNERSPRING MATTRESS WAS BEING USED ON THE 19-YEAR-OLD 5310 INVACARE BED ALONG WITH 6630 INVACARE HALF RAILS. THE USER MANUAL STATES ON PAGE 8 PART#1114836-H-05 - "DANGER! RISK OF DEATH, INJURY, OR DAMAGE; BED ACCESSORIES DESIGNED BY OTHER MANUFACTURERS; HAVE NOT BEEN TESTED BY INVACARE. USE OF NON-INVACARE BED ACCESSORIES MAY RESULT IN INJURY OR DEATH. USE ONLY INVACARE RAILS, MATTRESSES, BED EXTENDERS AND OTHER ACCESSORIES WITH INVACARE BED PRODUCTS." THE BED WILL NOT BE RETURNED. THE DEALER REPORTED THAT AFTER THE BED WAS CHECKED OUT, IT WAS SET UP FOR ANOTHER PATIENT AND IS IN USE. THERE WAS NO MALFUNCTION ALLEGED OR FOUND DURING THE DEALER INSPECTION. INVACARE HAS REQUESTED COPIES OF THE CORNER REPORTS AND PHOTOS. A FOLLOW-UP WILL BE FILED WITH ANY NEW INFORMATION RECEIVED.

    Description of Event or Problem · 1

    MEDWATCH REPORT (B)(4) RECEIVED FROM (B)(6) STATING: "ON CALL RN RECEIVED A CALL STATING PATIENT HAD PASSED AND DAUGHTER WAS HYSTERICAL. WHEN OCRN ARRIVED AT THE HOME, PT WAS DECEASED AND KNEELING ON THE LEFT SIDE OF THE BED WITH HER HEAD ENTRAPPED BETWEEN THE BED FRAME AND HALF SIDE RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866 SEMI-ELEC SNGLE CRANK HI/LO 9153638224 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA NA:5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death