BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 7728528 · Received July 27, 2018

    Report

    Report Number
    2020362-2018-00081
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    April 18, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS PREVIOUSLY REPORTABLE UNDER THE ASR EXEMPTION E2015006, WHICH WAS REVOKED ON 2018/06/28, RESULTING IN THIS MDR SUBMISSION. THE DEVICE WAS NOT RETURNED EVEN AFTER MULTIPLE ATTEMPTS. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED THE CUSTOMER. AN INVESTIGATION OF SIMILAR COMPLAINTS REVEALED SEVERAL POTENTIAL CAUSES, INCLUDING FAULTY OR DAMAGED COMPONENTS. MANY OF THESE PROBLEMS COULD BE A RESULT OF PHYSICAL TRAUMA AND/OR WEAR AND TEAR FROM REPEATED USE OF THE NURSE CALL CABLE. A REVIEW OF THE UNIT¿S DEVICE HISTORY RECORD (DHR) DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE DEVICE WAS SHOWN TO HAVE PASSED ALL VERIFICATION TESTING AND MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. 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. MANUFACTURER REFERENCE FILE (B)(4). PRODUCT WILL NOT BE RETURNING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM IS NOT SENDING A SIGNAL TO THE NURSE CALL STATION. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568805 KEEPSAFE DELUXE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8374

    Patients

    Seq Age Sex Outcome Treatment
    1