BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURY WHIRLPOOL SAFKARY CHAIR

    MDR report key: 7554 · Received January 12, 1994

    Report

    Report Number
    7554
    Event Type
    Malfunction
    Date Received
    January 12, 1994
    Date of Event
    November 8, 1993
    Report Date
    November 12, 1993
    Manufacturer
    CENTURY
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NURSING ASSISTANT REPORTED HE WAS TRANSPORTING RESIDENT BACK TO HER ROOM AFTER HER BATH USING THE BATH CHAIR. HE HAD JUST PUSHED HER INTO HER ROOM WHEN THE METAL SUPPORT ON THE LEFT LOWER HANDLE OF THE BATH CHAIR (LOWER PART) BROKE AT THE BEND. THE FRAME OF THE CHAIR WENT TO NA/R'S LEFT AND THE SEAT PART OF THE CHAIR (WITH RESIDENT STRAPPED IN) STARTED FALLING TO THE RIGHT. NA/R ATTEMPTED TO PULL UP RESIDENT BUT SHE FELL TO THE FLOOR LANDING ON HER RIGHT SIDE WITH HER RIGHT TEMPLE AREA HITTING THE FLOOR FIRST. RESIDENT WAS ASSESSED, HAD A LACERATION TO HER RIGHT KNEE & RIGHT TEMPLE. SHE WAS SENT BY AMBULANCE TO THE EMERGENCY ROOM FOR ASSESSMENT. X-RAY WERE NEGATIVE AND RESIDENT RETURNED TO NURSING HOME ON THE SAME DAY. SHE HAS A HEMATOMA ABOVE RIGHT EYE.THE BATH CHAIR WAS REMOVED IMMEDIATELY FROM THE AREA AND PLACED TEMPORARILY IN PHYSICAL THERAPY ROOM BEFORE BEING TAKEN DOWN TO PLANT SERVICE WORK ROOM.THE BROKEN AREA WAS VISUALLY ASSESSED AND THE PART OF CHAIR WHICH BROKE WAS FOUND TO BE RUSTED THROUGH ON THE BOTTOM SIDE. UPON VISUAL EXAMINATION, THE LEFT HANDLE LOWER BEND AREA IS ALSO RUSTED THROUGH.REVIEW OF PROCEDURE FOR PLACING OF RESIDENT IN SAFEKARY CHAIR WAS DOEN WITH NA/R. HE DEMONSTRATED CORRECT USAGE OF SAFEKARY CHAIR. HE STATED THE SAFETY LATCHES WERE ATTACHED ON BOTH LEFT AND RIGHT SIDE OF CHAIR PRIOR TO TRANSPORTING HER TO HER ROOM.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY WHIRLPOOL SAFKARY CHAIR NONE KIC CENTURY TUB#DCT 10V CHAIR POST #SL-10 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other