POSEY 8645WLRecalls & reported problems
Posey Products, LLC · Sitter On Cue Pro · Class 1
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00190676007639), received between Dec 13, 2023 and Sep 21, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (11 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 Alarm11
- Device Alarm System1
- Device Fell1
- Human-Device Interface Problem1
- Insufficient Device Problem Information1
- Intermittent Loss of Power1
- Loss of Power1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information3
- Ecchymosis1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50848032 ↗MalfunctionSep 21, 2026Intermittent Loss of Power
Patient problems: Insufficient Information
MAUDE report 50847504 ↗MalfunctionJun 17, 2026Device Alarm System
CUSTOMER REPORTED 1 ALARM UNIT NOT WORKING PROPERLY. ADVISED NURSE CALL ALARM IS NOT REACHING RAULAND SYSTEM. TRIED REPLACING AUX CORD, DID NOT RESOLVE ISSUE. SWAPPED ALARM UNIT AND ISSUE WAS RESOVLED. SN: (B)(6) NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534648 ↗MalfunctionMay 26, 2026Device Fell
PATIENT SITTING IN BEDSIDE RECLINER WHEN THE POSEY CHAIR ALARM BOX THAT HAD BEEN SECURED TO THE WALL, FELL OFF THE WALL HITTING THE PATIENT IN THE HEAD. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278832 ↗MalfunctionMay 26, 2026No Audible Alarm
PATIENT WAS PLACED ON CHAIR ALARM WITH POSEY SENSOR PAD IN PLACE AS THE PATIENT WAS A HIGH FALL RISK AND THEN PATIENT SLID OUT OF THE CHAIR AND NOTHING ALARMED AND EVERYTHING WAS PLUGGED IN. NO PATIENT INJURY AND NO VISBALE SIGNS OF DAMAGED ON ALARM OR SENSOR UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278674 ↗MalfunctionApr 16, 2026No Audible Alarm
CUSTOMER ADVISED SITTER ON CUE PRO AND CHAIR ALARM NOT WORKING PROPERLY. 8645WL SN: (B)(6) LOT UNKNOWN. PATIENT INVOLVEMENT FOR BOTH SKUS. 8645WL HAD DEAD BATTEIRES AND STAFF SAID THE ALARM DID NOT PROVIDE EARLY NOTIFICATION THAT BATTERIES WERE LOW. STAFF WERE NOT ALERTED FOR PATIENT WHO DID AN UNASSISTED CHAIR EXIT AND NEARLY HAD FALLEN. 8399 - PATIENT HAD BEEN USING THE HEADSTART BELT FOR ONE WEEK AND THE HOLD BUTTON ON THE ALARM DID NOT FUNCTION AS NORMAL WITH THIS BELT. STAFF REPLACED THE BELT WITH A NEW ONE AND THE HOLD FEATURE WORKED AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895713 ↗MalfunctionMar 11, 2026Human-Device Interface Problem
CUSTOMER REPORTED A PATIENT FALL WITH A BRUISE ON THE BACK OF THE HEAD. CUSTOMER ADVISED NO DAMAGE TO THE PRODUCTS, ISSUE RESULTED FROM HUMAN ERROR. RETURN DUE TO PATIENT INCIDENT. ITEM 8645WL, 8309WL.
Patient problems: Ecchymosis
MAUDE report 24572091 ↗MalfunctionAug 7, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 1 8645WL ALARM NOT WORKING PROPERLY. PATIENT FALL. POSEY ALARM HAD BEEN ARMED AND TESTED, BUT IT DID NOT SOUND UNTIL THE NURSE WAS ALREADY IN THE ROOM, AND THE PATIENT HAD ALREADY BEEN ON THE GROUND FOR ABOUT 30 SECONDS. THE TEAM CONFIRMED THAT THE PATIENT HAD BEEN ENTIRELY OFF THE PAD AND IT WAS NOT ON HOLD. NO PATIENT INJURY. SN: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746075 ↗MalfunctionApr 28, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 1 OF 8645WL NOT ALARMING. NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922030 ↗MalfunctionJan 28, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT 8645WL QTY 3, 8282WL WE DO NOT HAVE LOT #'S. ALARM #1 DID NOT ALARM WHEN PATIENT GOT UP. UNKNOWN IF SENSOR WAS PAIRED CORRECTLY. PATIENT FALL. NEW ALARM SWAPPED AND 2ND ALARM FAILED TO SOUND TOO WHICH IS ALARM #2. THESE WERE BOTH IN RM 478. NO INJURY FROM 2ND OR 1ST FALL. PRODUCT 8282WL KEPT TRIGGERING THE NURSE CALL SYSTEM FALSELY. COULD NOT BE CORRECTED UNTIL A DIFFERENT 8282WL WAS TESTED. 3RD ALARM GAVE AUDIBLE WARNING THAT MAINT WAS REQ'D. IT WOULD NOT ALARM WHEN PATIENT GOT OUT OF CHAIR. NO FALLS. TRIGGERED CHAIR EXIT ALARM WHILE PATIENT WAS LYING IN BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21256616 ↗MalfunctionJan 28, 2025No Audible Alarm; No Audible Alarm
ON (B)(6) 2025, BD1 CUSTOMER REPORTING A COMPLAINT ON PRODUCT#: (S) 8645WL QTY (B)(4), 8282WL WE DO NOT HAVE LOT#'S. (B)(6). ALARM #1 DID NOT ALARM WHEN PATIENT GOT UP. UNKNOWN IF SENSOR WAS PAIRED CORRECTLY. PATIENT FALL. NEW ALARM SWAPPED AND 2ND ALARM FAILED TO SOUND TOO WHICH IS ALARM #2. THESE WERE BOTH IN RM (B)(4). NO INJURY FROM 2ND OR 1ST FALL. PRODUCT: 8282WL KEPT TRIGGERING THE NURSE CALL SYSTEM FALSELY. COULD NOT BE CORRECTED UNTIL A DIFFERENT 8282WL WAS TESTED. 3RD ALARM GAVE AUDIBLE WARNING THAT MAINT WAS REQ'D. IT WOULD NOT ALARM WHEN PATIENT GOT OUT OF CHAIR. NO FALLS. TRIGGERED CHAIR EXIT ALARM WHILE PATIENT WAS LYING IN BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21256613 ↗MalfunctionJan 28, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT 8645WL QTY 3, 8282WL WE DO NOT HAVE LOT #'S. ALARM #1 DID NOT ALARM WHEN PATIENT GOT UP. UNKNOWN IF SENSOR WAS PAIRED CORRECTLY. PATIENT FALL. NEW ALARM SWAPPED AND 2ND ALARM FAILED TO SOUND TOO WHICH IS ALARM #2. THESE WERE BOTH IN RM 478. NO INJURY FROM 2ND OR 1ST FALL. PRODUCT 8282WL KEPT TRIGGERING THE NURSE CALL SYSTEM FALSELY. COULD NOT BE CORRECTED UNTIL A DIFFERENT 8282WL WAS TESTED. 3RD ALARM GAVE AUDIBLE WARNING THAT MAINT WAS REQ'D. IT WOULD NOT ALARM WHEN PATIENT GOT OUT OF CHAIR. NO FALLS. TRIGGERED CHAIR EXIT ALARM WHILE PATIENT WAS LYING IN BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21256601 ↗MalfunctionJan 14, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED THEY HAD A FEW ALARMS THAT DO NOT ACTIVATE THE CALL LIGHT FOR THE BED WHEN THE ALARM GOES OFF WHEN CONNECTED TO OUR SPLITTER 8235NCS. NO PATIENT INJURIES. SN: (B)(6). 1 OF 8645WL IS AVAILABLE FOR RETURN. NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21151793 ↗MalfunctionNov 21, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCTS 8645WL & 8309WL. CUSTOMER IS REPORTING A FALL INCIDENT INVOLVING A PATIENT. CUSTOMER DID NOT SPECIFY IF PATIENT WAS INJURED AS A RESULT. CUSTOMER STATES THAT THE FALL TOOK PLACE DUE TO THE ALARM NOT SOUNDING. THE NURSE THAT FOUND THE PATIENT SAID THAT THE UNIT AND PAD NEEDED TO BE PAIRED AGAIN.
Patient problems: Insufficient Information
MAUDE report 20750031 ↗MalfunctionSep 11, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED SITUATION WITH POSEY ON CUE PRO 8645WL SN UNKNOWN. CHAIR ALARM DID NOT ALERT STAFF WHEN BATTERY WAS LOW / ABOUT TO DIE. BACKGROUND: FAIRMONT M/S PATIENT ADMITTED TO ROOM 218 ON (B)(6) 2024, LATE AFTERNOON. ON (B)(6) 2024 @ 0700 RN SET UP THE CHAIR ALARM AS PATIENT WOULD BE GETTING TO THE CHAIR IN THE MORNING. NO ISSUES WITH SET UP PER RN. AT 0900 THE PATIENT ATTEMPTED TO GET OUT OF CHAIR AND ALARM DID NOT SOUND. WHEN RN WENT IN ROOM, THE BATTERY LIGHT UPPER RIGHT HAND CORNER OF ALARM WAS RED, MEANING BATTERY LOW/DEAD. ASSESSMENT PER NURSING STAFF, THE POSEY ALARM TYPICALLY PROVIDES A VERBAL CUE / MESSAGE THAT BATTERY IS LOW. THIS DID NOT OCCUR AT 0700 WHEN RN SET UP CHAIR ALARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20196889 ↗MalfunctionMay 22, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT #'S (B)(4). CUSTOMER STATES THAT A FALL OCCURRED WITH NO ALARM SOUNDING. WHEN THE STAFF TESTED THE ALARM THEY NOTICED THAT IT WOULD PAIR AND THEN DETACH WITHOUT SOUNDING AN ALARM OR VOICE/NOISE SOUNDING. THE PAD WAS NOT KEPT & WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19370475 ↗MalfunctionDec 13, 2023Loss of Power; Loss of Power
A CUSTOMER REPORTED THAT THEY HAVE EXPERIENCED AN INCREASE IN FALL RATES OVER THE LAST THREE MONTHS DUE TO BATTERIES IN THE ALARM BECOMING DEPLETED. STAFF STATED THEY COULD NOT CHANGE THE BATTERIES DUE TO THE BATTERY DOORS BEING TOO DIFFICULT TO OPEN. THE CUSTOMER ALSO STATED THAT FAIL RATES HAVE INCREASED TOO DUE TO THE NURSE CALL ADAPTER NOT ALERTING THE NURSE CALL SYSTEM. ALSO, THEY STATED THAT THEY WERE NOT GETTING LOW BATTERY NOTIFICATION DUE TO NOT BEING ABLE TO REPLACE THE BATTERIES. THE CUSTOMER STATED THAT THERE HAVE BEEN MULTIPLE PATIENT INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319957 ↗
Other Monitor, Bed Patient devices
- POSEY 8645Posey Products, LLC · Monitor, Bed Patient1 death60 reports
- Voalte Patient Safety 4.0Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- NaviCare® Patient Safety Systems 3.9Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- Cubby Beds KIT10001Sensory Medical, Inc. · Monitor, Bed Patient30 reports
- Medline MDT8450YMedline Industries, Inc. · MONITOR, BED PATIENT29 reports
- POSEY 8399Posey Products, LLC · Monitor, Bed Patient19 reports
- POSEY 8309ELPosey Products, LLC · Monitor, Bed Patient2 deaths19 reports
- POSEY 8345Posey Products, LLC · Monitor, Bed Patient1 death12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.