POSEY 8399Recalls & reported problems
Posey Products, LLC · CHAIR ALARM BELT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10190676006202), received between Mar 13, 2023 and Jul 17, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Break” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break9
- No Audible Alarm5
- Material Split, Cut or Torn2
- Activation, Positioning or Separation Problem1
- Malposition of Device1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information2
- Skin Tears2
- Abrasion1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862041 ↗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 24895728 ↗MalfunctionMar 6, 2026Activation, Positioning or Separation Problem
CUSTOMER REPORTED COMPLAINT THAT CAREGIVER REPORTED THAT THE BELT WAS APPLIED TO PATIENT CHAIR, AND PATIENT WAS FOUND WITH BELT AT NECK. THE BELT WAS APPLIED ON A PATIENT CHAIR ABOVE THE CHAIR ARMS, RATHER THAN IN BETWEEN ARMS AND SEAT OF CHAIR IN A GAP. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24536699 ↗MalfunctionFeb 27, 2026Patient-Device Incompatibility
CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT 8399. NO LOT# AVAILABLE. PRODUCT NOT AVAILABLE FOR RETURN. PATIENT INCIDENT BUT NO INJURY. CUSTOMER STATES THINNER/SMALLER PATIENTS ON RECLINER WAS ABLE TO ESCAPE THE CHAIR BELT WITHOUT RELEASING THE FRONT VELCRO STRAPS. THE BELT DID NOT ALARM AS A RESULT AND PATIENT WAS FOUND WALKING THE HALLS. IT IS UNKNOWN HOW THEY ACTUALLY GOT OUT OF THE BELT AND CHAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470090 ↗MalfunctionFeb 27, 2026Malposition of Device
CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT 8399. CUSTOMER STATES OT AT THE REHAB FACILITY NOTED THAT PATIENTS WERE PULLING BELTS OVER THEIR HEAD WHEN ON THE WHEELCHAIR. PATIENT INCIDENT BUT NO INJURY REPORTED, PRODUCT NOT AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470070 ↗MalfunctionJan 8, 2026Material Split, Cut or Torn
CUSTOMER STATED THAT THE SEAT BELT BROKE AT THE VELCRO. NO INCIDENT OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003255 ↗MalfunctionDec 10, 2025Break; Break
CUSTOMER IS REPORTING COMPLAINT ON PRODUCT 8399 THAT PRODUCT WOULD JUST FALL APART WHILE IN USE. LOT# 5230T141.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770212 ↗MalfunctionDec 10, 2025Break; Break
CUSTOMER IS STATING THAT PART 8399 WHILE IN USE PRODUCT JUST FALLS APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770190 ↗MalfunctionOct 21, 2025Break; Break
CUSTOMER REPORTED PRODUCT IS FAILING WHILE IN USE WITH THE PATIENT AND CONCERNED THAT MORE MAY FAIL AND CAUSE INJURIES. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352200 ↗MalfunctionOct 21, 2025Break; Break
CUSTOMER REPORTED PRODUCT IS FAILING WHILE IN USE WITH THE PATIENT AND CONCERNED THAT MORE MAY FAIL AND CAUSE INJURIES. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352199 ↗MalfunctionOct 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED AN INCIDENT WHERE ONE OF THE POSEY CHAIR BELTS RIPPED, LEADING TO A PATIENT SLIPPING FROM THE CHAIR. THIS WAS NOT PREVIOUSLY ESCALATED. PATIENT WAS INVOLVED BUT NOT INJURED. ITEM 8399, LOT# 5161T205.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316687 ↗MalfunctionSep 5, 2025Break; Break
CUSTOMER REPORTED COMPLAINT VIA EMAIL; RESULTED IN PATIENT INCIDENT AND INJURY. PER THE CUSTOMER: THE PATIENT LEANED OVER, PUTTING SOME WEIGHT ON THE BELT. THE BELT GAVE WAY AND THE PATIENT FELL. THE BELT ALARMED, AND ON INSPECTION THE BLUE VELCRO STRAP WAS NOT CONNECTED TO THE BELT. INJURY DESCRIPTION: SKIN TEAR TO ELBOW, ABRASION TO HEAD.
Patient problems: Abrasion; Skin Tears
MAUDE report 22986520 ↗MalfunctionDec 4, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT 8399. CUSTOMER STATES THAT FOOD LIQUID BECAME EMBEDDED IN THE VELCRO ATTACHMENT OF THE HEADSTART CHAIR SENSOR BELT, THIS CAUSED A NO ALARM WHICH LED TO A PATIENT INCIDENT/FALL. PATIENT SELF RELEASED THE BELT & ALARM DID NOT SOUND THEN PATIENT HAD A FALL, THE TYPE OF INJURY IS NOT SPECIFIED. PRODUCT IS NOT AVAILABLE FOR RETURN ACCORDING TO REPORT.
Patient problems: Insufficient Information
MAUDE report 20848924 ↗MalfunctionJul 2, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8399 LOT# 4072T170. CUSTOMER STATES THAT THEIR CUSTOMER HAD A BROKEN PRODUCT STRAP THAT DID NOT SOUND. THE PATIENT WAS NOT BARIATRIC OR COMBATIVE. 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 19662832 ↗MalfunctionJun 7, 2024Break; Break
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8399. CUSTOMER STATES THAT THEY HAD AN INCIDENT WITH A PATIENT FALLING OUT OF THEIR CHAIR WITH THE 8399 APPLIED. THE BELT RIPPED IN TWO PLACES. INFORMATION IS LIMITED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484930 ↗MalfunctionApr 17, 2024Break; Break
CUSTOMER REPORTING A COMPLAINT ON PRODUCT 8399. CUSTOMER STATES THAT A PATIENT WAS TRYING TO PUSH HERSELF BACK IN THE CHAIR AND THEN LEANED FORWARD AND THE 8399 BROKE. PATIENT STATED HER LEFT SHOULDER HURT.
Patient problems: Insufficient Information
MAUDE report 19126179 ↗MalfunctionApr 10, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8399. CUSTOMER STATES THAT VELCRO WAS NO FASTENED AND WAS LAYING TO THE SIDES OF THE CHAIR. THE ALARM SHOWED GREEN AND LOOKED ACTIVATED BUT NO SOUND. IT DID NOT ALARM WHEN THE PATIENT REMOVED VELCRO TAB. THE PATIENT SUFFERED A CUT ON THEIR HAND. ALARM WAS RESET AND SEEMED TO WORK THEN.
Patient problems: Skin Tears
MAUDE report 19082349 ↗MalfunctionJan 8, 2024Break; Break
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18464572 ↗MalfunctionMar 13, 2023No Audible Alarm; No Audible Alarm
THE CUSTOMER IS REPORTING A COMPLAINT ABOUT 8399. THE CUSTOMER STATES THAT PLENTY OF THEIR 8399 WILL NOT ALARM WHEN FIRST LAYER IS PULLED. THEY HAVE TRIED TO REMOVE THE 8399 AND PLUG BACK IN TO VERIFY ISSUE. IT DID ALARM WHEN THEY REMOVED THE BELT PLUG FROM THE ALARM. AFTER PLUGGING IT BACK IN AND THE GREEN LIGHT CAME ON THEY TRIED AGAIN THE 8399 WOULD NOT ALARM. 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 16533087 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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