BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2142600 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00282
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    PINGHU WEIFENG MATERIAL TECHNOLOGY
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER WAS SITTING ON THE SHOWER CHAIR WHEN THE LEG BROKE, CAUSING THE CONSUMER TO SINK TO THE FLOOR OF THE SHOWER. THE WEIGHT OF THE CONSUMER IS (B)(6) LBS AND THE HEIGHT IS (B)(6) INCHES. ANY ADDITIONAL LOADING ON THE DEVICE IS UNKNOWN. THE CONSUMER'S STABILITY IS UNKNOWN. THE CONSUMER'S MEDICATIONS ARE UNKNOWN. THE TIME OF DAY OR NIGHT OF THE INCIDENT IS UNKNOWN. THE SHOWERS ENVIRONMENTAL CONDITIONS AND SETUP ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER WAS SITTING ON THE SHOWER CHAIR WHEN THE LEG BROKE CAUSING THE CONSUMER TO SINK TO THE FLOOR OF THE SHOWER. THE WEIGHT OF THE CONSUMER IS (B)(6) AND THE HEIGHT IS (B)(6). ANY ADDITIONAL LOADING ON THE DEVICE IS UNKNOWN. THE CONSUMERS' STABILITY IS UNKNOWN. THE CONSUMERS' MEDICATIONS ARE UNKNOWN. THE TIME OF DAY OR NIGHT OF THE INCIDENT IS UNKNOWN. THE SHOWERS ENVIRONMENTAL CONDITIONS AND SETUP ARE UNKNOWN. (B)(4) 2011 - THE MANUFACTURER OF THIS DEVICE WAS ORIGINALLY LISTED AS (B)(4). CORRECTION: THE MANUFACTURER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4) THE MANUFACTURER WAS LISTED AS UNKNOWN. CORRECTION: THE MANUFACTURER IS (B)(4). PRODUCT WAS APPROXIMATELY 2 YEARS OLD AT TIME OF COMPLAINT. THIS IS A DISTRIBUTED PRODUCT. CONSUMER ALLEGES THE LEG BROKE AND HE HAD TO CRAWL OUT OF THE SHOWER. DEVICE WAS RETURNED ON (B)(4), INSPECTION RESULTS BELOW: VISUAL INSPECTION: CREASE IN BOTH SIDE HANDLES, LOWER LEG SECTION WAS BROKEN NEAR CENT MOUNTING HOLE, TWO OF FIVE RIVNUTS WERE PULLED OUTWARD AND DEFORMED THE PLASTIC SEAT, LEFT REAR RIVNUT WAS PULLED COMPLETELY OUT OF THE PLASTIC SEAT, LEGS ADJUSTED TO THE LOWEST SETTING BUT WERE NOT LOCKED, LEGS HAD MARKS INDICATING EXTENSION WERE ADJUSTED TO NUMBER THREE HEIGHT HOLE, LEG SECTIONS HAD SOAP RESIDUE. THERE WERE NO DISCREPANCIES NOTED FOR THE FUNCTIONAL TESTING. INSPECTION DID NOT DETERMINE ROOT CAUSE. NO SERIOUS INJURY ALLEGED. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER WAS SITTING ON THE SHOWER CHAIR WHEN THE LEG BROKE CAUSING THE CONSUMER TO SINK TO THE FLOOR OF THE SHOWER. THE WEIGHT OF THE CONSUMER IS (B)(6). ANY ADDITIONAL LOADING ON THE DEVICE IS UNKNOWN. THE CONSUMERS' STABILITY IS UNKNOWN. THE CONSUMERS' MEDICATIONS ARE UNKNOWN. THE TIME OF DAY OR NIGHT OF THE INCIDENT IS UNKNOWN. THE SHOWERS ENVIRONMENTAL CONDITIONS AND SETUP ARE UNKNOWN.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE BENCH WHEN THE LEG ALLEGEDLY BROKE, CAUSING THE CONSUMER TO SINK TO THE FLOOR OF THE SHOWER. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE BENCH WHEN THE LEG ALLEGEDLY BROKE, CAUSING THE CONSUMER TO SINK TO THE FLOOR OF THE SHOWER. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE BENCH WHEN THE LEG ALLEGEDLY BROKE, CAUSING THE CONSUMER TO SINK TO THE FLOOR OF THE SHOWER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX PINGHU WEIFENG MATERIAL TECHNOLOGY 91-2 PW091015

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR