BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 7053198 · Received November 22, 2017

    Report

    Report Number
    2020362-2017-00082
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    December 21, 2017
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS SCHEDULED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED IN BY MANUFACTURING AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. 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 WARRANTED. MANUFACTURER REFERENCE FILE # (B)(4). NO PRODUCT RETURNED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THE PRODUCT IS FUNCTIONING AS DESIGNED IN ALARMING WHEN WEIGHT WAS REMOVED FROM THE SENSOR PAD. THE ALARM PASSED FUNCTIONAL TESTING AND WE WERE UNABLE TO REPLICATE CUSTOMER'S COMPLAINT OF THE PRODUCT NOT ALARMING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WAS IN USE BY HIS GRANDMOTHER ON THE COUCH AND THE ALARM DID NOT SOUND WHEN HER WEIGHT WAS REMOVED FROM SENSOR. AS A RESULT THE CUSTOMER BROKE BOTH LEGS RESULTING IN SURGERY AND A METAL ROD BEING PLACED IN HER LEG. CUSTOMER ALSO ADDED THE GRANDMOTHER SUFFERS FROM SHAKY LEGS SYNDROME. THE DATE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    SUPPLEMENTAL REQUIRED FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833510 KEEPSAFE DELUXE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability