BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 14518191 · Received May 26, 2022

    Report

    Report Number
    2182318-2022-00045
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Report Date
    June 9, 2022
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS REQUESTED TO BE RETURNED AND HAS NOT BEEN RECEIVED. THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT DATABASE REVEALED SIMILAR COMPLAINTS OF 8374 ALARMS EITHER SOUNDING WHEN THEY SHOULDN¿T OR NOT SOUNDING WHEN THEY SHOULD. INVESTIGATIONS INTO THESE COMPLAINTS REVEALED THAT THE MOST LIKELY CAUSE OF THE REPORTED COMPLAINT IS EITHER DAMAGE TO THE SENSOR RECEPTACLE OR DAMAGE TO THE RJ-11 CLIP. DAMAGE CAN CAUSE THE PINS INSIDE THE SENSOR RECEPTACLE TO BECOME STUCK DOWN, EITHER TRIGGERING NO ALARM OR FALSE ALARM. IT CAN ALSO CAUSE THE SENSOR CABLE TO NOT HAVE A SECURE FIT IN THE RECEPTACLE, WHICH CAN ALLOW MOVEMENT TO AFFECT FUNCTION. LIKEWISE WITH DAMAGE TO THE SENSOR CABLE CLIP. OTHER CAUSES, SUCH AS CORROSION AND MOISTURE DAMAGE, ARE ALSO A POSSIBILITY. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES 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 OR SENSOR IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, OR IF THE CHAIR BELT SENSOR IS UNFASTENED. 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. MANUFACTURE REFERENCE FILE (B)(4) PENDING PRODUCT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED WITH DEEP SCRATCHES AND INDENTATIONS OBSERVED ON THE EXTERIOR HOUSING. THE LED COVER HAS BEEN PUSHED DOWN INTO THE UNIT AS IT'S LOOSE OR NO LONGER ATTACHED ON THE UPPER ENCLOSURE. THE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWDER RESIDUE ON BATTERY FLAT CONTACTS, BATTERY SPRINGS, AND COMPARTMENT SIDEWALL. THE EVALUATION DID NOT CONFIRM THE REPORTED ISSUE AS THE UNIT SOUNDED PROPERLY WHEN IN USE WITH A SENSOR PAD. HOWEVER, THE PRE-RECORDED VOICE MESSAGE PLAYED WITH STATIC SOUNDS WHEN THE UNIT WAS SET TO THE VOICE ONLY AND VOICE & TONE MODES DUE TO A FAULTY COB1 (VOICE CHIP). IF THERE IS STATIC WHEN THE MESSAGE PLAYS, THE ALARM WILL STILL ALERT THE CAREGIVER OF A PATIENT EXIT AND IS UNLIKELY TO CONTRIBUTE TO A PATIENT INCIDENT. BEING THAT THE UNIT IS ALREADY MORE THAN SIX YEARS OLD, IT IS LIKELY THAT 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 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).

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL THEY HAVE 4 ALARMS THAT WILL ALARM ON THEIR OWN, BUT ONCE CONNECTED TO SENSOR PAD, IT WON'T MAKE ANY NOISE OR ALARM. REQUESTING CREDIT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    SUPPLEMENTAL NEEDED FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606612 KEEPSAFE DELUXE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO TIDI PRODUCTS, LLC 8374 1938KE0518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown