POSEY 8645Recalls & reported problems
Posey Products, LLC · SITTER ON CUE · Class 1
Quick summary
This Posey Sitter On Cue is a bed and chair patient monitor that alerts staff when a patient gets up. The 60 reports mostly describe the alarm staying silent — not sounding when a patient leaves the bed or chair, sometimes with a status light that still looks normal, plus loose connections and battery-related power loss. Reports also mention one death and three injuries, including a patient fall after a belt sensor strap failed to activate. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10190676007131), received between Aug 29, 2022 and Sep 18, 2026 — classified as 1 death, 3 injuries, 56 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (41 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.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm41
- Intermittent Loss of Power4
- Delayed Alarm3
- Appropriate Device Problem Term/Code Not Available2
- Battery Problem2
- Communication or Transmission Problem2
- Loose or Intermittent Connection2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Insufficient Information13
- Bone Fracture(s)3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Laceration(s)2
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831305 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PATIENT FALL DURING USE. ITEM 8645 LOT UNKNOW, REQUEST FOR BOTH ALARM AND SENSOR PAD TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788804 ↗MalfunctionJun 18, 2026Overheating of Device
CUSTOMER REPORTED AN ADVERSE EVENT WITH OUR 8645 ALARM UNIT. THEY BELIEVE IT MAY HAVE BEEN A BATTERY RELATED INCIDENT, WHERE THE DEVICE APPEARED TO LET OUT A SMALL PUFF OF SMOKE WHEN STAFF WERE SETTING UP THE DEVICE PRIOR TO USE WITH A PATIENT, RESULTING IN A SMALL AREA OF DAMAGE TO THE COATING ON THE AAA BATTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553231 ↗MalfunctionApr 20, 2026No Audible Alarm
CUSTOMER REPORTED ALARMS WITH MULITPULE ISSUES. SN: (B)(6) BED ALARM ONLY FLASHES AND WILL NOT WORK ON CHAIR. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931639 ↗MalfunctionMar 26, 2026No Audible Alarm; Use of Device Problem
CUSTOMER REPORTED 1 8398L AND 1 8645 ALARM UNIT RESULTING IN A PATIENT FALL. PATIENT WAS IN BED BELT, BUT SENSOR VELCRO STRAPS OF BED BELT WERE NOT ALIGNED MEANING THE SENSOR WAS NOT ACTIVATED. THE PATIENT GOT OUT OF THE BELT WITHOUT ALARMING AND FELL. PRODUCTS ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFO.
Patient problems: Insufficient Information
MAUDE report 24706939 ↗MalfunctionMar 25, 2026No Audible Alarm
CUSTOMER REPORTED SITTER ON CUE NOT WORKING PROPERLY. SN: (B)(6) - NOT ALARMING WHEN CONNECTED TO CHAIR SENSOR. STATUS LIGHT INDICATES GREEN. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687635 ↗MalfunctionMar 6, 2026No Audible Alarm
CUSTOMER REPORTED 1 SITTER ON CUE ALARM NOT WORKING PROPERLY. ADVISED ALARM IS NOT ALARMING WHEN THE CHAIR SENSOR PRESSURE IS RELEASED. ALARM WILL ALERT VIA NURSE CALL STATION / SYSTEM. ALSO NOTICED THAT THE ALARM WILL PERIODICALLY ANNOUNCE LOW BATTERY WHEN THE BOX IS IN STANDBY MODE BUT IT DOESN?T SEEM TO WHEN THE SENSOR PAD IS ACTIVATED. TM TROUBLSHOOTED VIA UNIT MODES. CONFIRMED ALARM WAS SET TO TONE MODE. TESTED UNIT AGAIN AND COULD HEAR 1 BEEP WHEN PRESSURE WAS LIFTED. VALIDATED ALARM WOULD PERIODICALLY ANNOUNCE LOW BATTERY WHEN ALARM IS IN STANDBY BUT DID NOT STATE LOW BATTERY WHEN SENSOR PAD WAS ACTIVATED. DEVICE WAS IN USE WITH A PATIENT AND THE PATIENT WAS INJURED. DEVICE WAS FOUND TO HAVE LOW BATTERY AFTER THE EVENT. SN: (B)(6).
Patient problems: Insufficient Information
MAUDE report 24533504 ↗MalfunctionFeb 11, 2026No Audible Alarm
CUSTOMER REPORTED 1 SITTER ON CUE ALARM NOT WORKING PROPERLY. BATTERIES HAVE BEEN CHANGED SEVERAL TIMES HOWEVER NO SOUND WHEN PATIENT GETS UP. NO PATIENT INJURY. SN: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318671 ↗MalfunctionFeb 4, 2026Loose or Intermittent Connection
COMPLAINT REPORTED VIA PHONE THAT PORT 2 WOULD NOT RECOGNIZE THE SENSOR (INTERMITTENT CONNECTION). SN (B)(6). NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260763 ↗MalfunctionJan 30, 2026No Audible Alarm
CUSTOMER REPORTED VIA PHONE THAT 8645 ALARM IS NO LONGER WORKING AS INTENDED. SN ENDING IN (B)(6) SPEAKER FAULTY AND NOT WORKING. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222470 ↗MalfunctionOct 24, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 1 ALARM UNIT DID NOT ALARM WHEN IT SHOULD HAVE. PATIENT WAS INJURED. NO FURTHER INFORMATION WAS PROVIDED. SN: (B)(6).
Patient problems: Insufficient Information
MAUDE report 23381402 ↗MalfunctionOct 16, 2025Intermittent Loss of Power; Intermittent Loss of Power
CUSTOMER REPORTED THE POWER SWITCH WILL INTERMITTENTLY WORK (OCCASIONAL POWER). SN (B)(6).
Patient problems: Insufficient Information
MAUDE report 23316646 ↗MalfunctionJul 2, 2025Intermittent Loss of Power; Intermittent Loss of Power
CUSTOMER REPORTED ALARM NOT WORKING PROPERLY. ADVISED THE UNIT IS COMPLETELY NON FUNCTIONAL AND BARLEY MAKES A STATIC NOISE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384178 ↗MalfunctionJun 30, 2025Intermittent Loss of Power; Intermittent Loss of Power
CUSTOMER REPORTED COMPLAINT VIA EMAIL, - NO POWER WITH PART 8645WL SN (B)(6). NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359402 ↗MalfunctionJun 26, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED COMPLAINT THAT ALARM DID NOT SOUND, RESULTING IN A PATIENT FALL. SENSOR PAD WILL ALSO BE RETURNED WITH THE ALARM (8283). NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341811 ↗MalfunctionJun 4, 2025Intermittent Loss of Power; Intermittent Loss of Power
CUSTOMER REPORTED ALARMS WITH VARYING ISSUES. INTERMITTENT POWER ISSUES IDENTIFIED DURING EVALUATION OF COMPLAINT UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145336 ↗MalfunctionMay 14, 2025No Audible Alarm; No Audible Alarm
CUSTOM REPORTED AN ALARM THAT MALFUNCTIONED, PATIENT WAS FOUND ON HIS KNEES WHEN THE ALARM DID NOT SOUND. SN (B)(6).
Patient problems: Insufficient Information
MAUDE report 22020816 ↗MalfunctionMay 2, 2025No Audible Alarm; No Audible Alarm
CUSTOMER HAD PATIENT FALL WITH OUR ALARM. ALARM DID NOT SOUND; BATTERIES WERE CHANGED AND ALARM WORKED AS INTENDED. LIMITED INFORMATION AS TM WILL BE VISITING CUSTOMER TO OBTAIN FURTHER INFO. NO SN AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21950445 ↗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.
Patient problems: Laceration(s)
MAUDE report 21673658 ↗MalfunctionMar 19, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED ALARM NOT WORKING PROPERLY. ALARM WILL BLINK AMBER (SN: (B)(6) BUT DOES NOT PRODUCE ANY SOUNDS. NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647896 ↗MalfunctionJan 30, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 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 THE ALARM WAS TURNED 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 DURING THE INCIDENT WHICH INDICATES THAT THE LOW BATTERY POWER MAY HAVE BEEN THE CA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277144 ↗MalfunctionJan 10, 2025No Audible Alarm; No Audible Alarm
(B)(6) 2024 (B)(6) REPORTED VIA EMAIL. A PATIENTS ALARM BATTERIES DIED AND THE ALARM DID NOT ALERT STAFF THAT THE BATTERIES WERE DEAD.THE DEAD BATTERIES WERE IDENTIFIED AFTER THE PATIENT FELL. FORTUNATELY, THERE WERE NO INJURIES TO THE PATIENT. THE ALARM HAS BEEN REMOVED FROM SERVICE AND REPLACED WITH A NEW ALARM. SN: (B)(6) PLEASE ADVSIE ON QA RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21130692 ↗MalfunctionDec 3, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED A PATIENT FALL FOR PART 8645. ALARM WAS PLUGGED INTO ONE OF THE SENSOR PADS, ALARM DID NOT ALERT. PATIENT STOOD UP AND FELL. (B)(6).
Patient problems: Insufficient Information
MAUDE report 20833594 ↗MalfunctionNov 12, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED UNIT NOT ALARMING AND FLASHING YELLOW. SENSOR WERE CHECKED AND SENSOR PORT 2 IS WORKING PROPERLY. SENSOR PORT 1 IS NOT WORKING AS INTENDED. SN: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20666719 ↗MalfunctionNov 5, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED THE ALARM FAILURES DID RESULT IN A PATIENT INCIDENT, BUT MORE OF A NEAR MISS SITUATION. THE ALARMS DID NOT TRIGGER THE LARGE-SCALE ALERT TO THE MAIN NURSE? STATION (NO SIGNAL TO NURSE CALL SYSTEM), THEY WERE ONLY AUDIBLE NEAR THE ROOM THEY WERE PLACED IN. STAFF DID NOT RECEIVE PAGER ALERTS FROM NURSE CALL TO LET THEM KNOW THE ALARMS WERE GOING OFF. PATIENTS WERE HIGH FALL RISK BUT WE WERE ABLE TO RESPOND QUICK ENOUGH (WE WERE NEAR THE ROOMS AT THE TIME) TO AVOID PATIENT FALLS. (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611108 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.