BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHAIR CHECK DEVICE

    MDR report key: 53363 · Received December 4, 1996

    Report

    Report Number
    MW1010359
    Event Type
    Other
    Date Received
    December 4, 1996
    Date of Event
    November 29, 1996
    Report Date
    December 2, 1996
    Manufacturer
    BED-CHECK CORP.
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SITTING IN W/C WITH BED MONITOR SYSTEM IN USE. ALARM ON, CHAIR PAD CORRECTLY PLACED UNDER PT. CHAIR PAD WITHIN RECOMMENDED USE PERIOD. PT ATTEMPTED TO GET OUT OF W/C. ALARM DID NOT SOUND. PT FELL TO FLOOR. TO ER FOR EVALUATION. C/O PAIN IN BACK. NO FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHAIR CHECK DEVICE BED MONITOR KMI BED-CHECK CORP. 65815 - 030 *

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other