POSEY 8309ELRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10190676004369), received between Aug 29, 2022 and Sep 16, 2026 — classified as 2 deaths, 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PATIENT FALL DURING USE. ITEM 8309EL LOT 961967, REQUEST FOR BOTH ALARM AND SENSOR PAD TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788820 ↗
• InjurySep 1, 2026No Audible Alarm

  CUSTOMER REPORTED AT LEAST THREE INCIDENTS- TWO OF WHICH RESULTED IN INJURY FALLS WHERE THE PATIENT WAS FOUND OUT OF THEIR CHAIR. NOT ALARMING AND CONTINUED BLINKING GREEN INDICATING THE UNIT WAS ACTIVE.THE CUSTOMER HAD PERSONALLY INVESTIGATED ALL THREE OCCURRENCES AND CONFIRMED THE CHAIR PADS WERE NOT DETECTING WEIGHT WHEN APPLIED OR REMOVED ALARMS WERE SWITCHED WITH NEW PADS AND WORKED. ONLY TWO PADS ARE AVAILABLE FOR RETURN. LOT#'S 5205T188 AND 6098T235.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550670 ↗
• InjurySep 1, 2026No Audible Alarm

  ADDITIONAL PAD REPORTED AS MALFUNCTIONING THAT RESULTED IN A NON-INJURY PATIENT FALL ON (b)(6) 2026. CUSTOMER REPORTED AT LEAST THREE INCIDENTS- TWO OF WHICH RESULTED IN INJURY FALLS WHERE THE PATIENT WAS FOUND OUT OF THEIR CHAIR. NOT ALARMING AND CONTINUED BLINKING GREEN INDICATING THE UNIT WAS ACTIVE.THE CUSTOMER HAD PERSONALLY INVESTIGATED ALL THREE OCCURRENCES AND CONFIRMED THE CHAIR PADS WERE NOT DETECTING WEIGHT WHEN APPLIED OR REMOVED ALARMS WERE SWITCHED WITH NEW PADS AND WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550668 ↗
• InjurySep 1, 2026No Audible Alarm

  CUSTOMER REPORTED AT LEAST THREE INCIDENTS- TWO OF WHICH RESULTED IN INJURY FALLS WHERE THE PATIENT WAS FOUND OUT OF THEIR CHAIR. NOT ALARMING AND CONTINUED BLINKING GREEN INDICATING THE UNIT WAS ACTIVE.THE CUSTOMER HAD PERSONALLY INVESTIGATED ALL THREE OCCURRENCES AND CONFIRMED THE CHAIR PADS WERE NOT DETECTING WEIGHT WHEN APPLIED OR REMOVED ALARMS WERE SWITCHED WITH NEW PADS AND WORKED. ONLY TWO PADS ARE AVAILABLE FOR RETURN. LOT#'S 5205T188 AND 6098T235.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550667 ↗
• InjurySep 1, 2026No Audible Alarm

  CUSTOMER REPORTED AT LEAST THREE INCIDENTS- TWO OF WHICH RESULTED IN INJURY FALLS WHERE THE PATIENT WAS FOUND OUT OF THEIR CHAIR. NOT ALARMING AND CONTINUED BLINKING GREEN INDICATING THE UNIT WAS ACTIVE.THE CUSTOMER HAD PERSONALLY INVESTIGATED ALL THREE OCCURRENCES AND CONFIRMED THE CHAIR PADS WERE NOT DETECTING WEIGHT WHEN APPLIED OR REMOVED ALARMS WERE SWITCHED WITH NEW PADS AND WORKED. ONLY TWO PADS ARE AVAILABLE FOR RETURN. LOT#'S 5205T188 AND 6098T235.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550664 ↗
• MalfunctionMar 23, 2025No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED 1 8645 / 1 OF 8309EL NOT WORKING AS INTENDED. PHYSICAL THERAPY HAD A PATIENT UP IN A CHAIR, SHE HAD ENSURED EVERYTHING WAS DONE CORRECTLY TO HELP PREVENT A FALL. DUE TO THE ALARM NOT WORKING, THE PATIENT UNFORTUNATELY WAS ABLE TO GET UP OUT OF CHAIR AND FALL. PT ALSO TRIED IT AGAIN ON HERSELF AND IT STILL DIDNT ALARM. PATIENT INJURY DID OCCUR (FALL). LIMITED INFORMATION PROVIDED. NOT LOT AND OR SN.

  Patient problems: Laceration(s)

  MAUDE report 21673659 ↗
• MalfunctionJan 30, 2025No Audible Alarm; No Audible Alarm

  PATIENT WAS SITTING IN BEDSIDE RECLINER AND SLID OUT OF CHAIR. THE POSEY ALARM DID NOT GO OFF AND DID NOT NOTIFY NURSE CALL. THE POSEY ALARM WAS ON, AND SENSOR WAS PLUGGED INTO ALARM, NURSE CALL WAS PLUGGED IN. WHEN NURSE PLACED PATIENT IN CHAIR THE ALARM DID SAY CHAIR SENSOR ACTIVATED. FOLLOWING THE INCIDENT THE NURSE SET UP THE PAD (SAME ONE WITH PATIENT) AND TESTED BY PUSHING ON THE PAD. THEY MADE A VIDEO RECORDING TO GO ALONG WITH THIS COMPLAINT. IN THE VIDEO IT CAN BE SEEN THAT AFTER THE SENSOR IS ACTIVATED AND THE NURSE LIFTS PRESSURE OFF THE PAD TO TRIGGER ALARM, THE ALARM STATUS LIGHT FLASHES AND VOICE QUE SAYS SENSOR ATTACHED, BUT ALARM DOES NOT GO OFF. IN THE VIDEO IT CAN BE SEEN THAT THERE IS A LOW BATTERY LIGHT FLASH INDICATING THAT THE ALARM HAD LOW BATTERY. THE CUSTOMER WAS USING PROCELL BATTERIES AND WHEN I TURNED THE ALARM ON, THE LOW BATTERY INDICATOR LIGHT FLASHED AND THE ASSOCIATE ON SITE DID HEAR LOW BATTERY VOICE FROM SPEAKER. THE HOSPITAL USES AC POWER TYPICALLY, BUT IT WAS VERIFIED IN VIDEO AND FROM NURSE THAT THE AC POWER ADAPTER WAS NOT PLUGGED INTO ALARM URING THE INCIDENT WHICH INDICATES THAT THE LOW BATTERY POWER MAY HAVE BEEN THE CAUSE OF WHY THE ALARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277636 ↗
• InjuryAug 13, 2024No Audible Alarm; No Audible Alarm

  REPORTED COMPLAINT RECEIVED FROM (B)(6) HOSPITAL. WE JUST HAD A FALL WITH A SERIOUS INJURY, APPEARS A CHAIR ALARM DID NOT GO OFF, BEING INSPECTED BY BIO MED, BUT CANNOT FIND ANYTHING WRONG, RISK IS GIVING UP NEXT STEPS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19973147 ↗
• MalfunctionJul 26, 2024No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED (B)(6) , INNOVATION NURSE SPECIALIST OF (B)(6) HEALTH, CONTACTED ME TODAY TO REPORT AN INCIDENT INVOLVING OUR CHAIR SENSOR (B)(6) AND ON CUE ALARM (8645). INCIDENT HAPPENED LAST NIGHT ON (B)(6) 2024. PATIENT GOT UP FROM CHAIR TO USE THE BATHROOM AND FELL ON THE WAY TO THE BATHROOM. PATIENT WAS NOT INJURED, AS FAR AS SHE KNOWS. THE PATIENTS NURSE STATED THAT THE ALARM DID NOT GO OFF. THEY LATER TESTED THE CHAIR ALARM WITH A NEW SENSOR AND IT WORKED. THEY HAVE THE LOT # AND SERIAL NUMBER OF THE ALARM AND WILL SEND TO ME ON MONDAY. I ASKED IF THEY KEPT THE ALARM AND SENSOR PAD AND THEY HAVE IT, SO WE CAN SEND IT BACK TO QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840551 ↗
• MalfunctionJul 2, 2024No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8645. CUSTOMER STATES THAT A PATIENT WAS BEING MONITORED BY SENSOR & 8645 ALARM. PATIENT GOT UP THE ALARM DID NOT SOUND. PATIENT SUFFERED A FALL AND LACERATION TO THEIR HEAD. THE 8645 S/N (B)(6) IS AVAILABLE FOR RETURN BUT SENSOR WAS DISPOSED OF BY THE CUSTOMER.

  Patient problems: Laceration(s)

  MAUDE report 19656025 ↗
• MalfunctionApr 30, 2024No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTING A COMPLAINT ON (B)(6). MEDWATCH COMPLAINT # (B)(6). CUSTOMER STATES THAT LOT # 3173T155 WAS USED WITH A PATIENT WHO FELL OUT OF THEIR CHAIR WITHOUT THE ALARM SOUNDING. THE PRODUCT MALFUNCTIONED THE CUSTOMER REPORTED. THE INFORMATION GIVEN IS LIMITED.

  Patient problems: Insufficient Information

  MAUDE report 19215630 ↗
• MalfunctionMar 20, 2024Device Alarm System; Device Alarm System

  CUSTOMER REPORTED WE HAD AN INCIDENT WHERE A PATIENT WAS SITTING IN THE CHAIR WITH THE CHAIR SENSOR PAD UNDERNEATH AND CONNECTED APPROPRIATELY TO THE CHAIR ALARM BOX AS INDICATED BY THE GREEN LIGHT. THE PATIENT WENT TO BEND OVER TO PICK SOMETHING UP IN WHICH THE CHAIR ALARM ACTIVATED APPROPRIATELY. HOWEVER, THE PATIENT SOMEHOW GOT UP OUT OF THE CHAIR WITHOUT THE CHAIR ALARM ALARMING AND WHEN STAFF WENT INTO THE ROOM TO PERFORM THEIR HOURLY CHECK, THE CHAIR ALARM BOX HAD AN ORANGE FLASHING LIGHT ON THE BOX. NOW, IN REVIEWING THE QUICK START GUIDE, THERE IS NOT AN ORANGE LIGHT BUT RATHER A YELLOW LIGHT THAT INDICATES SENSOR WILL BEGIN MONITORING ONCE PRESSURE IS APPLIED. CURIOUS IF THIS IS A POTENTIAL MALFUNCTION OF THE CHAIR ALARM OR WHAT ARE YOUR THOUGHTS ON WHAT MIGHT HAVE OCCURRED. NO SERIAL NUMBER DETERMINED, SENSOR PAD (B)(6) ALSO REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941005 ↗
• MalfunctionJan 16, 2024Delayed Alarm; No Audible Alarm; Delayed Alarm; No Audible Alarm

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8645 & 8309EL. CUSTOMER STATES THEY HAD 3 PATIENT INCIDENT FALLS WHERE THE SITTER ON CUE DID NOT ACTIVATE OR HAD DELAYED ACTIVATION. ALL 3 INCIDENTS INVOLVED THE SENSOR # 8309EL. ONE OF THE THREE FALLS RESULTED IN AN INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18519118 ↗
• MalfunctionDec 13, 2023Device Sensing Problem; Device Sensing Problem

  CUSTOMER IS REPORTING COMPLAINT ON PRODUCT # 8309EL, LOT# 3250T141. CUSTOMER STATES THAT THE PAD WILL NOT SENSE PATIENT SITTING ON IT WHILE PAD IS ON TOP OF CHAIR WAFFLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320030 ↗
• MalfunctionNov 7, 2023No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8309EL. CUSTOMER STATES THAT A PATIENT SLID OFF THE FRONT OF THEIR CHAIR AND WAS FOUND PRONE ON THE FLOOR WITH A CONTUSION TO LEFT EYEBROW. CUSTOMER STATES THAT THE ALARM DID NOT SOUND AND MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088299 ↗
• MalfunctionOct 18, 2023Excessive Heating; Excessive Heating

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # V8309EL. CUSTOMER STATES THAT WHILE A SENSOR PAD WAS IN USE IT HEATED UP ENOUGH TO BURN THE PATIENT. THE CUSTOMER REPORTS THAT NO INJURIES RESULTED FROM THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959073 ↗
• MalfunctionFeb 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SITTER ON CUE ALARM WITH A SERIAL NUMBER (B)(4) AND 8309EL SENSOR WERE REPORTED WITH A PATIENT FALL. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379726 ↗
• DeathOct 27, 2022No Audible Alarm; No Audible Alarm

  TIDI PRODUCTS RECEIVED A LEGAL SUMMONS REGARDING A PATIENT DEATH AT (B)(6) MEDICAL CENTER WHILE UTILIZING POSEY SITTER ELITE ITEM #8345. SUMMONS NOTED INCORRECT SITTER ELITE MODEL NUMBER, HOWEVER THE MODEL NUMBER WAS CONFIRMED BY (B)(6) MEDICAL CENTER ATTORNEY. PATIENT WAS UNDER FALLS MANAGEMENT CARE PLAN, WHICH INCLUDED THE SITTER ELITE ALARM. A FALL WAS REPORTED THAT RESULTED IN AN INTRACRANIAL HEMORRHAGE THAT RESULTED IN A PATIENT DEATH. IN THE SUMMONS, IT INDICATES THAT THE ALARM DID NOT SOUND.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15678178 ↗
• DeathAug 29, 2022No Audible Alarm; No Audible Alarm

  PER (B)(6) VIA EMAIL: "ON CUE ALARM AND CHAIR SENSOR - PATIENT HAD A FALL. THE PATIENT DID NOT SURVIVE THE FALL. THE DATE OF THE INCIDENT WAS NOT SHARED. THE ALARM AND SENSOR HAVE BEEN PULLED FROM THE UNIT AND IS WITH BIOMED. BIOMED HAS ASKED THAT I COME IN TO MEET WITH THEM AND LOOK AT THE ALARM AND SENSOR AND VERIFY WHAT SETTINGS IT IS ON."

  Patient problems: Insufficient Information

  MAUDE report 15316713 ↗