BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 7773201 · Received August 10, 2018

    Report

    Report Number
    2020362-2018-00071
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Report Date
    July 23, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED IN WITH SCRATCHES AND INDENTATIONS TO THE EXTERIOR HOUSING. PREVIOUS BATTERY CORROSION COULD ALSO BEEN SEEN IN THE BATTERY COMPARTMENT AND THE BACK OF THE BATTERY DOOR. THE UPPER ENCLOSURE OF THE HOUSING IS ALSO LOOSE RESULTING IN THE LED COVER BEING PUSHED DOWN INTO THE UNIT. UPON OPENING OF THE ALARM, THE NURSE CALL RECEPTACLE WAS FOUND TO BE ELEVATED FROM THE PRINTED CIRCUIT BOARD AND HAD A BROKEN PIN. WITH THE BROKEN, THE NURSE CALL FEATURE COULD NOT BE PUT INTO USE. BEING THAT THIS UNIT IS MORE THAN SIX YEARS OLD, IT IS LIKELY THE CAUSE IS EXPECTED NORMAL WEAR AND TEAR. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES "TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, OR MAGNET IS REMOVED FROM FACE PLATE." THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE NURSE CALL PORT IS NOT SENDING SIGNAL TO THE NURSES STATION. TROUBLESHOOTING OF THE ALARM FOUND THE CONNECTION BETWEEN THE CABLE AND THE NURSE CALL RECEPTACLE IS NOT SECURE. THE DATE THE ISSUE WAS DISCOVERED IS NOT KNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613525 KEEPSAFE DELUXE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8374

    Patients

    Seq Age Sex Outcome Treatment
    1