POSEY V8309ELRecalls & reported problems

Posey Products, LLC · NOVAPLUS SENSOR, CHAIR, · 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 10190676006301), received between Dec 17, 2025 and Dec 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (2 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

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

Most reported problems

Device problems

No Audible Alarm2

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionDec 18, 2025No Audible Alarm; No Audible Alarm
SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 23838790 ↗
MalfunctionDec 17, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED SENSOR IS NOT WORKING PROPERLY. PATIENT WAS UP IN THE CHAIR WITH CHAIR ALARM HOOKED UP AND WORKING. NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830417 ↗

Device details

UDI-DI	`10190676006301`
Brand	POSEY
Model	V8309EL
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	Not in Commercial Distribution
Record updated	Feb 19, 2026

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.

Other Monitor, Bed Patient devices

POSEY 8645
Posey Products, LLC · Monitor, Bed Patient
1 death60 reports
Voalte Patient Safety 4.0
Hill-Rom, Inc. · MONITOR, BED PATIENT
1 recall0 reports
NaviCare® Patient Safety Systems 3.9
Hill-Rom, Inc. · MONITOR, BED PATIENT
1 recall0 reports
Cubby Beds KIT10001
Sensory Medical, Inc. · Monitor, Bed Patient
30 reports
Medline MDT8450Y
Medline Industries, Inc. · MONITOR, BED PATIENT
29 reports
POSEY 8399
Posey Products, LLC · Monitor, Bed Patient
19 reports
POSEY 8309EL
Posey Products, LLC · Monitor, Bed Patient
2 deaths19 reports
POSEY 8645WL
Posey Products, LLC · Monitor, Bed Patient
17 reports

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.