DISPOSABLE BED SENSOR BELT

Additional Manufacturer Narrative

H3 PRODUCT HAS BEEN RECEIVED BUT EVALUATION OF THE DEVICE WAS NOT COMPLETED AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE 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 NEVER JERK OR PULL ON CORD TO REMOVE PLUG FROM ALARM. DOING SO MAY DAMAGE THE CORD OR PLUG AND MAY CAUSE THE BELT TO FAIL. ALWAYS USE PLASTIC TAB TO RELEASE THE PLUG. IF VELCRO STRAPS BECOME WET, ALARM MAY NOT SOUND. EXCESS MOISTURE MAY PREVENT SENSOR FROM ACTIVATING, INCREASING RISK OF INJURY. IF STRAPS BECOME WET, DISCONTINUE USE UNTIL COMPLETELY DRY. IF NECESSARY, USE A STIFF BRUSH TO REMOVE DUST AND LINT FROM HOOK- AND-LOOP. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. MANUFACTURER REFERENCE FILE (B)(4).

Description of Event or Problem

CUSTOMER REPORTED COMPLAINT VIA EMAIL FOR ITEM 8398 (QTY: 3). BELT #1 (3087T167): WHEN PLUGGED INTO THE POSEY ALARM, THE GREEN LIGHT STAYS ON EVEN WHEN THE BELT IS "OPEN". BELT #2 (B)(6): WHEN THE BELT IS APPLIED TO THE PATIENT AND CLOSED CORRECTLY, THE ALARM WILL NOT ACTIVATE (NO GREEN LIGHT). BELT #3 (3059T061): WHEN THE BELT IS PLUGGED IN, THE POSEY ALARM WILL FLASH MULTIPLE COLORS OR IT WILL BE GREEN WHILE OPENED. DIFFERENT MALFUNCTIONS. REPORTED BY (B)(6).

Additional Manufacturer Narrative

EVALUATION OF THE RETURNED PRODUCT FOUND THE RETURNED SENSOR BELT DID NOT SOUND WHEN THE HOOK AND LOOP FASTENERS ARE DISENGAGED. WHEN PRESSURE IS APPLIED CLOSER TO THE EYELET CONNECTORS, THE SENSOR BELT WOULD TRIGGER THE ALARM TO SOUND INDICATING THAT THERE IS A DISCONNECTED WIRE INSIDE. POSSIBLE CAUSE FOR THIS ISSUE IS WEAR AND TEAR, OPERATIONAL ERROR/MISUSE, AND /OR EXCESSIVE PULLING OF THE WIRING. BEING THAT THERE WERE SEVERAL COMPLAINTS FOR BELTS THAT DID NOT SOUND WHEN THE HOOK AND LOOK WERE DISENGAGED, THIS ISSUE IS BEING CONTAINED TO ADDRESS THE IDENTIFIED MISUSE. THE 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 NEVER JERK OR PULL ON CORD TO REMOVE PLUG FROM ALARM. DOING SO MAY DAMAGE THE CORD OR PLUG AND MAY CAUSE THE BELT TO FAIL. ALWAYS USE PLASTIC TAB TO RELEASE THE PLUG. IF VELCRO STRAPS BECOME WET, ALARM MAY NOT SOUND. EXCESS MOISTURE MAY PREVENT SENSOR FROM ACTIVATING, INCREASING RISK OF INJURY. IF STRAPS BECOME WET, DISCONTINUE USE UNTIL COMPLETELY DRY. IF NECESSARY, USE A STIFF BRUSH TO REMOVE DUST AND LINT FROM HOOK- AND-LOOP. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE 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

SUPPLEMENTAL MEDWATCH IS BEING SENT FOR ADDITIONAL INFORMATION.