POSEY 8399SLRecalls & reported problems

Posey Products, LLC · 8399 CHAIR ALARM BELT 3FT · Class 1

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190676007933), received between Mar 26, 2024 and Oct 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
No Audible Alarm1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 28, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 1 ALARM BELT 8399SL LOT 5196T243 RIPPING AS WELL AS NOT CONNECTED PROPERLY TO THE POSEY SITTER BOXES. THEY ARE PLUGGED INTO THE RECEIVER BUT IT DOES NOT CHANGE THE INDICATOR LIGHT FROM YELLOW TO GREEN & THUS NEVER ALARMS WHEN UNDONE. PATIENT DID HAVE A FALL BUT NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408798 ↗
MalfunctionMar 26, 2024Break; Break
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 8399SL. CUSTOMER STATES THAT THEY HAD AN ADDITIONAL SEATBELT(8399) BREAK. NO INJURY OR FALL TO THE PATIENT. THE CUSTOMER FURTHER STATES THAT THE BELT WAS APPLIED CORRECTLY, NO SNAGGING OR PULL BY WHEELCHAIR, AND THE BELT BROKE IN THE SAME EXACT SPOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980993 ↗

Device details

UDI-DI	`10190676007933`
Brand	POSEY
Model	8399SL
Company	Posey Products, LLC
Product code	KMI · Monitor, Bed Patient
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 14, 2022

Device type (GMDN): Patient-monitoring bed mattress cover

A device shaped to fit over a bed mattress and intended to monitor the status of patient movement in relation to the bed while providing comfort for the patient in bed. It consists of soft, waterproof textiles with built-in light sensors/optical cable(s) to detect patient movement and connects to a control unit which interfaces with a healthcare monitoring/call system to signal an alarm situation. It may be used to prevent falls over the bedrails, provide monitoring of patient movement/breathing, and/or monitor patient presence/absence. It is treated with an antibacterial agent to inhibit bacterial growth on the cover and can be laundered for cleaning. This is a reusable device.

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All Monitor, Bed Patient devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.