BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWING AWA ARM CARECLINER

    MDR report key: 4036267 · Received August 13, 2014

    Report

    Report Number
    1027229-2014-00002
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 7, 2014
    Manufacturer
    WINCO MFG., INC.
    Product Code
    FRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 ADVISED THE CLINIC TO REMOVE THE CHAIR FROM SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, WINCO RECEIVED A CALL FRO, (B)(4), TECHNICAL OPERATIONS MANAGER WITH (B)(4). MR. (B)(4) ADVISED WINCO'S CUSTOMER CARE MANAGER ((B)(4)) THAT ONE OF THEIR PATIENT IS CLAIMING THEY WERE BURNED WHEN SITTING IN A 6940 SWING AWAY ARM CARECLINER WHILE RECEIVING TREATMENT. THE PATIENT HAD BEEN ASLEEP IN THE RECLINE POSITION FOR TWO HOURS PRIOR TO THE COMPLAINT. THE PATIENT REPORTED THAT HIS CHAIR WAS ABOUT TO BLOW UP AND WAS HOT. THE NURSE ON DUTY EXAMINED THE CHAIR WITHIN MINUTES OF THE INITIAL COMPLAINT. THE NURSE INDICATED THAT THERE WAS NO VIBRATION OR WARMTH DETECTED AND THAT THE OPERATING SWITCH WAS NOTED TO BE IN THE OFF POSITION. PATIENT WENT IMMEDIATELY TO HIS DOCTOR AND THE DOCTOR WAS UNABLE TO FIND ANY VISIBLE BURN MARKS. THE DOCTOR ADVISED THE PATIENT THAT DUE TO HIS MEDICAL CONDITION (NEUROPATHY) IF HE LAYS DOWN FOR ANY LENGTH OF TIME HE WILL FEEL A BURNING SENSATION ON HIS SKIN. THE PATIENT ADVISED THE DOCTOR THAT THE CHAIR HAD BURNT HIM ON THE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483082 SWING AWA ARM CARECLINER CLINICAL RECLINER FRJ WINCO MFG., INC. 6940 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR