Posey 8309WLRecalls & reported problems

Posey Products, LLC · SITTER ON CUE PRO WIRELESS CHAIR PAD, TAP-2-PAIR · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 7
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190676007653), received between Nov 12, 2024 and Jun 9, 2026 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (6 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

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

Most reported problems

Device problems

No Audible Alarm6
Human-Device Interface Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions3
Insufficient Information2
Ecchymosis1
Laceration(s)1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

DeathJun 9, 2026No Audible Alarm
ON 5/13/2026, A COMPLAINT WAS REPORTED THAT A PATIENT WAS FOUND OUT OF A CHAIR AFTER AMBULATING TO THE BATHROOM AND HAD REMOVED A PICC LINE, RESULTING IN FLUID EXPOSURE. THE PATIENT WAS ALSO ATTEMPTING TO INSERT DENTURES. THE POSEY ALARM WAS ACTIVE (GREEN LIGHT ON) BUT DID NOT ALERT WHEN THE PATIENT EXITED THE CHAIR. STAFF CONFIRMED THE ALARM REMAINED ACTIVE DESPITE THE EVENT. THE PATIENT WAS LATER TRANSFERRED TO HOSPICE AND SUBSEQUENTLY PASSED AWAY.
Patient problems: Insufficient Information
MAUDE report 25443106 ↗
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278734 ↗
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 24572103 ↗
MalfunctionAug 20, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED, ACCORDING TO THE RN, THE PATIENT SAT ON THE CHAIR ALARM, HEARD THE BEEP, AND GOT UP FOR A LITTLE SO THE NURSE COULD ADJUST THE CHAIR PAD, AND SAT BACK DOWN. WHEN THE PATIENT GOT UP , THE CHAIR ALARM DID NOT ALARM. PATIENT INJURY, PATIENT SUSTAINED MINOR INJURY TO RIGHT KNEE. CHAIR SENSOR NOT AVAILABLE, AS THIS HAS BEEN DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850093 ↗
MalfunctionJan 23, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTING A COMPLAINT ON PRODUCT 8309WL LOT# 4304T148. CUSTOMER STATE THAT THEY RECENTLY HAD A PATIENT INCIDENT ON (B)(6) 2024. THE PATIENT WAS IN THEIR CHAIR WITH OUR 8309WL PAIRED TO THE ALARM. THE PATIENT GOT UP AND FELL. ALERTED STAFF BY YELLING. THE ALARM DID NOT SOUND WHEN THE PATIENT STOOD UP. A FOLEY WAS PULLED OUT AND A LACERATION OCCURED. STAFF RE-PAIRED THE SENSOR & ALARM AND IT STILL DIDN'T SOUND ALARM. STAFF TRIED A NEW SENSOR, THE NEW SENSOR WORKED CORRECTLY PAIRED/SOUNDED. CUSTOMER HAS ORIGINAL PAD STILL TO RETURN FOR EVALUATION.
Patient problems: Laceration(s)
MAUDE report 21223603 ↗
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 THE PATIENT SAID THAT THE UNIT AND PAD NEEDED TO BE PAIRED AGAIN.
Patient problems: Insufficient Information
MAUDE report 20750034 ↗
MalfunctionNov 12, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED THAT THEY HAVE HAD PATIENT FALL INCIDENT DUE TO A NEW BATCH OF SENSOR PADS LOT: 4218T065. THEY HAD PURCHASED THESE ON (B)(6). THIS IS A NEW ISSUE FOR THEM. TM ALERTED TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20665769 ↗

Device details

UDI-DI	`00190676007653`
Brand	Posey
Model	8309WL
Company	Posey Products, LLC
Product code	KMI · Monitor, Bed Patient
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 31, 2024

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 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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