POSEY 8399LRecalls & reported problems
Posey Products, LLC · CHAIR ALARM BELT LONG · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10190676006288), received between Mar 6, 2024 and Aug 13, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- No Audible Alarm3
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Chest Pain1
- Pelvic Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241269 ↗MalfunctionJul 27, 2026Break
Patient problems: Chest Pain; Pelvic Pain
MAUDE report 50020444 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50020416 ↗MalfunctionNov 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED WHILE IN USE ON A PATIENT, PRODUCT FELL APART WHILE READJUSTING ON PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605490 ↗MalfunctionJul 26, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED EARLIER IN THE MONTH, IN THE FIRST WEEK OF JUNE, WE HAD TWO INSTANCES WHERE WE FOUND PATIENTS OUT OF THEIR SEATBELTS, BUT THE ALARMS WERE NOT SOUNDING. UPON REVIEW WE FOUND THAT THE BELTS WERE TORN, AT WHAT APPEARS TO BE A SEAM. NEITHER BELT WAS TIGHT OR MOUNTED IN AN UNUSUAL WAY. 1ST BELT: LOT #3304T084. 2ND BELT: LOT #4059T038. THEN, A WEEK LATER (6/12), WE HAD A PATIENT FALL. THE PATIENT HAD REMOVED THEIR SEATBELT, THE ALARM SOUNDED BRIEFLY AND THEN STOPPED. OUR NURSE MANAGER AND THERAPY MANAGER ASSESSED THE BOX AND OUT OF 4 ATTEMPTS TO TRIGGER THE ALARM, IT ONLY WORKED PROPERLY ONCE. BELT LOT #3304T084.
Patient problems: Insufficient Information
MAUDE report 19840201 ↗MalfunctionJul 25, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED EARLIER IN THE MONTH, IN THE FIRST WEEK OF JUNE, WE HAD TWO INSTANCES WHERE WE FOUND PATIENTS OUT OF THEIR SEATBELTS, BUT THE ALARMS WERE NOT SOUNDING. UPON REVIEW WE FOUND THAT THE BELTS WERE TORN, AT WHAT APPEARS TO BE A SEAM. NEITHER BELT WAS TIGHT OR MOUNTED IN AN UNUSUAL WAY. 1ST BELT: LOT #3304T084. 2ND BELT: LOT #4059T038. THEN, A WEEK LATER (6/12), WE HAD A PATIENT FALL. THE PATIENT HAD REMOVED THEIR SEATBELT, THE ALARM SOUNDED BRIEFLY AND THEN STOPPED. OUR NURSE MANAGER AND THERAPY MANAGER ASSESSED THE BOX AND OUT OF 4 ATTEMPTS TO TRIGGER THE ALARM, IT ONLY WORKED PROPERLY ONCE. BELT LOT #3304T084.
Patient problems: Insufficient Information
MAUDE report 19833192 ↗MalfunctionMar 21, 2024No Audible Alarm; No Audible Alarm
TM REPORTED COMPLAINT VIA EMAIL. ISSUE OCCURRED WITH SN (B)(6) (EXPIRED ALARM), BUT RESULTED WITH A PATIENT INCIDENT INJURY. PER THE TM: SITTER ELITE ALARM WITH THE 8399L-HEADSTART CHAIR BELT. ALARM DID NOT GO OFF WHEN PATIENT SELF-RELEASED THE HEADSTART BELT. PATIENT FELL AT 3 PM TODAY AND IS ON THEIR WAY TO HAVE CT SCAN TO IDENTIFY ANY INJURIES.
Patient problems: Insufficient Information
MAUDE report 18951406 ↗MalfunctionMar 6, 2024Break; Break
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8399L. (B)(6). CUSTOMER STATES THEY HAD A CLEAN BREAK OF 8399L WITH A PATIENT IN A WHEELCHAIR. THE BREAK CAUSED THE PATIENT TO FALL FORWARD. THE PATIENT DID NOT SUFFER ANY INJURIES. THE BELT BROKE JUST BEFORE THE BOX STITCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18852013 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.