DISPOSABLE CHAIR ALARM BELT

Additional Manufacturer Narrative

WITHOUT THE RETURN OF THE DEVICE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. HISTORICAL REVIEW OF THE COMPLAINT DATABASE FOR THE LAST TWO YEARS REVEALED 3 OTHER INSTANCES WHERE THE BELT RIPPED AT THE SEAMS. TWO OF THE COMPLAINTS WERE RETURNED FOR EVALUATIONS, AND INVESTIGATIONS REVEALED USER ERROR AS THE FOAM MATERIALS OF THE RETURNED SENSOR BELT WERE BEING TORN APART. THE OTHER COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE SALES REPORT SHOWS THAT THERE WERE 370,645 UNITS SOLD IN THE LAST TWO YEARS, MAKING THE COMPLAINT RATE (B)(4) PERCENT, WHICH IS A LOW OCCURRENCE. NO LOT NUMBER WAS PROVIDED. FOR THIS REASON, A REVIEW OF THE DHR CANNOT BE PERFORMED. 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 ENSURE ALL PARTS OF THE SYSTEM ARE OPERATIONAL BEFORE LEAVING THE PATIENT UNATTENDED. FAILURE TO FOLLOW THE INSTRUCTIONS COULD RESULT IN SERIOUS INJURY. BEFORE LEAVING THE PATIENT UNATTENDED, EXPLAIN THE PURPOSE FOR THE BELT. MAKE SURE THE PATIENT UNDERSTANDS THE NEED TO CALL FOR ASSISTANCE BEFORE EXITING THE CHAIR AND HOW TO SELF-RELEASE. ADDITIONALLY, THE PRECAUTIONS SECTION INDICATES THAT THIS PRODUCT IS A NON-INVASIVE WAY TO MONITOR PATIENT MOVEMENT. THIS DEVICE DOES NOT PREVENT FALLS AND IS NOT A SUBSTITUTE FOR GOOD NURSING AND REGULAR VISUAL MONITORING. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT THIS TIME. MANUFACTURER REFERENCE FILE 2023-01482.

Description of Event or Problem

CUSTOMER STATES THAT THE 8399 BELT SNAPPED IN A CLEAN BREAK RIGHT AT WHERE THE WHITE ALARM PORTION MEETS THE REST OF THE BELT. CUSTOMER THOUGHT THIS WAS ODD SINCE THIS AREA IS ONE OF THE MORE REINFORCED AREA OF THE BELT. THE BELT WAS THROWN AWAY SO IT WILL NOT BE RETURNED.