BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE CARE CLINER W/SWING AWAY ARMS

    MDR report key: 4647435 · Received March 30, 2015

    Report

    Report Number
    1027229-2015-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    December 31, 2014
    Report Date
    February 27, 2015
    Manufacturer
    WINCO MFG LLC
    Product Code
    FRJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY CONTACTED WINCO ABOUT THE INCIDENT, BY PHONE, ON 12/31/2014 BUT REFUSED TO RETURN THE CHAIR TO WINCO FOR EVAL UNTIL 01/29/2015. THIS IS THE "BECOMES AWARE" DATE THAT WE USED. ON 02/27/2015, ADVISED CLINIC TO INSPECT THEIR REMAINING RECLINERS FOR WORN OR INCORRECTLY INSTALLED WIRING HARNESS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 WINCO CUSTOMER SVC REC'D A CALL FROM (B)(6), AREA TECH OPERATIONS MGR FOR FRESENIUS MEDICAL CARE. HE INFORMED US THAT A 6940 ELITE CARE CLINER HAD OVERHEATED DURING A PT TREATMENT AND LEFT A BURN PATTERN ON THE CHAIR BACK CUSHION AND THE PTS PILLOW. THE PT INITIALLY HAD RED MARKS ON HIS BACK SIMILAR TO A SUNBURN. THE PT REFUSED TO GO TO THE HOSP. UPON COMPLETION OF DIALYSIS, THE PT HAD ONLY A SMALL RED MARK ON HIS BACK. PT REC'D NO MEDICAL CARE FOR THE RED MARKS (B)(4).THE FACILITY REFUSED REPEATED REQUESTS FROM WINCO TO RETURN THE RECLINER FOR EVAL FOR APPROXIMATELY ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208319 ELITE CARE CLINER W/SWING AWAY ARMS CLINICAL RECLINER, 6940-19-TB-HM FRJ WINCO MFG LLC 6940 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK