POSEY 8374Recalls & reported problems

Posey Products, LLC · POSEY KEEPSAFE DELUXE · Class 1

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190676002143), received between Oct 6, 2023 and Feb 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Insufficient Device Problem Information1
Loose or Intermittent Connection1
No Audible Alarm1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 8, 2024No Audible Alarm; No Audible Alarm
CUSTOMER STATES THAT THEY HAD A PATIENT INCIDENT/FALL WHERE THE ALARM DID NOT SOUND. NO INJURIES OR DEATH AS A RESULT OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18669040 ↗
MalfunctionDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER IS REPORTING COMPLAINT ON PRODUCT # 8374. CUSTOMER STATES THERE WAS A SENTIANL EVENT INVOLVING THE POSEY ALARM. NO OTHER GIVEN INFO WAS GIVEN REGARDING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 18409151 ↗
MalfunctionOct 6, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
CUSTOMER STATES THAT THE ALARM IS MALFUNCTIONING. THE ALARM DOES NOT CONSISTENTLY SENSE WHEN WEIGHT IS REMOVED FROM A SENSOR PAD. IT WILL SOMETIMES BLINK RED AND THEN SOMETIMES GREEN. BATTERIES HAVE HAD INTERMITTENT ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17889209 ↗

Device details

UDI-DI	`10190676002143`
Brand	POSEY
Model	8374
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	Nov 3, 2022

Device type (GMDN): Nurse call system

An assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.

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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.