POSEY 8309Recalls & reported problems
Posey Products, LLC · SINGLE PATIENT USE CHAIR · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190676004352), received between Sep 4, 2024 and Feb 17, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (4 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
Most reported problems
Device problems
- No Audible Alarm4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026No Audible Alarm
CUSTOMER REPORTED COMPLAINT VIA EMAIL ISSUE WITH ITEM 8309 (QTY: (B)(4), PRODUCT RESULTED IN A PATIENT FALL. TWO SENSORS HAVE THE SAME LOT (#5268T212), ONE HAS A DIFFERENT LOT (#5261T220). THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372271 ↗MalfunctionFeb 17, 2026No Audible Alarm
CUSTOMER REPORTED COMPLAINT VIA EMAIL ISSUE WITH ITEM 8309 (QTY: 3), PRODUCT RESULTED IN A PATIENT FALL. TWO SENSORS HAVE THE SAME LOT (#5268T212), ONE HAS A DIFFERENT LOT (#5261T220). THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372190 ↗MalfunctionFeb 17, 2026No Audible Alarm
CUSTOMER REPORTED COMPLAINT VIA EMAIL ISSUE WITH ITEM: 8309 (QTY: (B)(4), PRODUCT RESULTED IN A PATIENT FALL. TWO SENSORS HAVE THE SAME LOT (#5268T212), ONE HAS A DIFFERENT LOT (#5261T220). THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24372045 ↗MalfunctionSep 4, 2024No Audible Alarm; No Audible Alarm
SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 20138350 ↗
Other Monitor, Bed Patient devices
- POSEY 8645Posey Products, LLC · Monitor, Bed Patient1 death60 reports
- Voalte Patient Safety 4.0Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- NaviCare® Patient Safety Systems 3.9Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- Cubby Beds KIT10001Sensory Medical, Inc. · Monitor, Bed Patient30 reports
- Medline MDT8450YMedline Industries, Inc. · MONITOR, BED PATIENT29 reports
- POSEY 8399Posey Products, LLC · Monitor, Bed Patient19 reports
- POSEY 8309ELPosey Products, LLC · Monitor, Bed Patient2 deaths19 reports
- POSEY 8645WLPosey Products, LLC · Monitor, Bed Patient17 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.