N/A 8309ELRecalls & reported problems

Stryker Sustainability Solutions, Inc. · Posey Chair Alarm Pad, 30 Days, 8' Long Cord · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327500196), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Component Missing1

Patient problems

Intracranial Hemorrhage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJun 21, 2022Component Missing; Component Missing
IT WAS REPORTED THE SENSOR DID NOT COME WITH THE GRIPPER FABRIC IN THE PACKAGE. THIS ALLOWED THE ALARM SENSOR PAD TO SLIDE BENEATH THE PATIENT AND WEDGE BETWEEN TWO PRESSURE-PRODUCING SURFACES OF THE RECLINER CHAIR (FOLD OF THE CHAIR BETWEEN THE BACK AND SEAT). THE ALARM SOUNDED AND FUNCTIONED AS DESIGNED IMMEDIATELY WHEN THE ALARM SENSOR PAD WAS REMOVED FROM BETWEEN THE SURFACES OF THE CHAIR, GIVING NO CAUSE TO DISCONTINUE USE OF THE ALARM OR THE ALARM SENSOR PAD. THE PATIENT SLID OUT OF THE CHAIR BECAUSE THE SENSOR WAS NOT HELD IN PLACE DUE TO THE LACK OF GRIPPER PROVIDED. THIS CAUSED A SERIOUS SAFETY EVENT RESULTING IN AN INTRACRANIAL BLEED REQUIRING SURGICAL INTERVENTION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Intracranial Hemorrhage
MAUDE report 14761804 ↗

Device details

UDI-DI	`07613327500196`
Brand	N/A
Model	8309EL
Company	Stryker Sustainability Solutions, Inc.
Product code	KMI · MONITOR, BED PATIENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 2023

Device type (GMDN): Bed/chair occupant movement pressure/vibration sensor

An electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. Some types are able to detect in addition occupant respiration and heart rates; and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.

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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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