BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 12018238 · Received June 17, 2021

    Report

    Report Number
    2020362-2021-00033
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Report Date
    July 23, 2021
    Manufacturer
    POSEY PRODUCTS, LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENGINEERING INVESTIGATION REVEALED THE SENSOR PAD WAS NOT RETURNED FLAT AS IT WAS FOLDED AND STUFF INSIDE THE NON-POSEY BOX WITH THE 8345 ALARM UNIT. BASED OFF THE RETURNED UNITS THE FAILURE MODE OF HAVING THE SENSOR PAD RJ-11 BREAK WHEN CONNECTED TO AN ALARM THAT IS SECURELY ATTACHED TO SOMETHING IS POSSIBLE. A REPEATED EXPERIMENT WAS PERFORMED WITH A NEW SENSOR PAD AND RETURNED ALARM AND MANUALLY ENOUGH FORCE IS POSSIBLE TO BREAK THE WIRE AND LEAVE THE SENSOR PAD RJ-11 STUCK IN THE ALARM UNIT. THE TRADE-OFF OF HAVING THE SENSOR PAD CORD BREAK (IN THE SAME MANNER OBSERVED IN THIS EVENT) ALLOWS THE ALARM TO STILL ALERT AND ALERT THE CAREGIVER EVEN THOUGH THE SENSOR PAD RJ-11 COMPONENT IS STUCK IN THE ALARM. THIS IS THE DESIGNED FAIL SAFE TO ENSURE THE ALARM ALWAYS ALERTS IN THE CASE OF THE SENSOR PAD CORD BEING PULLED AND BREAKING IN A CLINICAL SETTING. 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. THE ALARM AND SENSOR PAD IFU STATES IN SEVERAL PLACES THE IMPORTANCE TO ROUTE THE CORD TO AVOID POTENTIAL TRIPPING HAZARDS. 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. REFERENCED MANUFACTURER FILE NUMBER (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED US VIA E-MAIL. THE CUSTOMER STATED THAT THEY HAD A PATIENT INCIDENT INVOLVING MAJOR INJURY. OUR ALARM AND SENSOR PRODUCTS WERE IN USE AT THE TIME. THE SENSOR PRODUCT WHICH I AM LOOKING FOR MORE INFORMATION ON WAS DAMAGED IN THE INCIDENT. CUSTOMER STATES "GOOD MORNING WE HAD A PATIENT WHO HAD THE POSEY ALARM UNDER HER. SHE FELL ALARM DIDN'T GO OFF. UPON INSPECTION IT WAS FOUND THAT THE PAD HAD BROKEN LOOSE. THE PATIENT SUFFERED A MAJOR INJURY. ANYONE ELSE SEEING ISSUES? I WANTED TO MAKE SURE THAT MAYBE IT WASN'T A LOT ISSUE OR SOMETHING. HOPE YOU ARE WELL! TALK SOON (B)(6)." I AM SENDING E-MAIL AND CALLING FOR ADDITIONAL INFORMATION, BUT AT THE TIME INFORMATION IS LIMITED TO THAT STATEMENT. NO GTIN/LOT #/SN HAS YET BEEN PROVIDED. A TS TEMPLATE HAS BEEN COMPLETED AND SAVED TO THE DRIVE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RECEIVED IN FOR EVALUATION. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE WIRE (SENSOR CABLE) ATTACHED TO THE PAD CAME APART FROM THE PLASTIC JACK (RJ-11 CONNECTOR) THAT IS INSERTED INTO THE ALARM. THE PLASTIC JACK IS STILL IN THE ALARM. WHEN THE ALARM IS TURNED ON, IT ALARMS APPROPRIATELY; HOWEVER, THERE IS NOTHING, BUT THE PLASTIC JACK IS STILL INSIDE THE ALARM. THE PATIENT DID ACQUIRE SOME INJURIES FROM THE FALL. THE PATIENT WAS ABLE TO THROW HERSELF OUT OF THE STRETCHER AND ONTO THE FLOOR. THE PATIENT REQUIRED TRANSPORT TO ANOTHER FACILITY BUT HAS SINCE RECOVERED AND IS DOING WELL. THE CUSTOMER PROVIDED SOME PHOTOS OF THE ALARM AND SENSOR THAT WERE USED BY THE PATIENT. THE POSSIBLE CAUSE OF THE EVENT IS THAT THE PATIENT WAS ABLE TO PULL THE SENSOR CABLE EXCESSIVELY WHILE IT WAS CONNECTED TO THE ALARM CAUSING THE CABLE TO COME APART. ADDITIONALLY, SENSOR PAD FOR TYPICAL BED HAD BEEN USED, THEY DID NOT USE THE SENSOR PAD THAT IS INTENDED FOR THE STRETCHER. WITHOUT THE RETURN OF THE DEVICE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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. REFERENCED MANUFACTURER FILE NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED US VIA E-MAIL. THE CUSTOMER STATED THAT THEY HAD A PATIENT INCIDENT INVOLVING MAJOR INJURY. OUR ALARM AND SENSOR PRODUCTS WERE IN USE AT THE TIME. THE SENSOR PRODUCT WHICH I AM LOOKING FOR MORE INFORMATION ON WAS DAMAGED IN THE INCIDENT. CUSTOMER STATES "GOOD MORNING WE HAD A PATIENT WHO HAD THE POSEY ALARM UNDER HER. SHE FELL ALARM DIDN'T GO OFF. UPON INSPECTION IT WAS FOUND THAT THE PAD HAD BROKEN LOOSE. THE PATIENT SUFFERED A MAJOR INJURY. ANYONE ELSE SEEING ISSUES? I WANTED TO MAKE SURE THAT MAYBE IT WASN'T A LOT ISSUE OR SOMETHING. HOPE YOU ARE WELL! TALK SOON (B)(6)." I AM SENDING E-MAIL AND CALLING FOR ADDITIONAL INFORMATION, BUT AT THE TIME INFORMATION IS LIMITED TO THAT STATEMENT. NO GTIN/LOT #/SN HAS YET BEEN PROVIDED. A TS TEMPLATE HAS BEEN COMPLETED AND SAVED TO THE DRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915796 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS, LLC 8345 1832KF1265

    Patients

    Seq Age Sex Outcome Treatment
    1