POSEY 8283Recalls & reported problems
Posey Products, LLC · DISPOSABLE BED SENSOR · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10190676004376), received between Apr 25, 2023 and May 20, 2026 — classified as 1 injury, 7 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
- Adverse Event Without Identified Device or Use Problem3
- Device Alarm System1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Pressure Sore/Ulcer2
- Fall1
- Laceration(s)1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026No Audible Alarm
CUSTOMER REPORTED A PATIENT FALL DUE TO A FAULTY BED SENSOR PAD PART 8283 SN (B)(6). ALARM WAS VERIFIED TO NOT BE THE AFFECTED ITEM, HOWEVER THE CUSTOMER IS REQUESTING EVALUATION AS WELL.
Patient problems: Insufficient Information
MAUDE report 25230917 ↗MalfunctionFeb 25, 2026No Audible Alarm
FDA COMPLAINT RECEIVED REPORT (B)(4). PER CUSTOMER REPORT, THE BED ALARM WAS PLACED UNDER THE PATIENT. BED ALARM WOULD NOT ARM IN POSEY MONITOR.
Patient problems: Insufficient Information
MAUDE report 24443890 ↗MalfunctionJun 26, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED COMPLAINT THAT ALARM DID NOT SOUND, RESULTING IN PATIENT FALL. SENSOR PAD WILL ALSO BE RETURNED WITH THE ALARM (8283). NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341821 ↗MalfunctionJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PART 8283 METAL CLIPS CAUSED CUTS ON PATIENT SKIN. NO LOT NUMBER. OCCURRED: UNKNOWN DATE CUSTOMER STATED THIS HAPPENED A FEW MONTHS AGO.
Patient problems: Laceration(s)
MAUDE report 22287954 ↗MalfunctionJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED COMPLAINT, CAREGIVER REPORTED THAT PATIENTS DEVELOP DEEP TISSUE INJURIES FROM USE OF BED PAD ON MATTRESS.
Patient problems: Pressure Sore/Ulcer
MAUDE report 22287929 ↗MalfunctionMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED A PATIENT WITHOUT PRESSURE INJURY DEVELOPED A PRESSURE INJURY SITTING ON BED SENSOR PAD UNDER SHEET ON MATTRESS. PATIENT INVOLVEMENT, NO LOT# PROVIDED. PRODUCT IS NOT AVAILABLE FOR RETURN AND OR EVALUATION. NO FURTHER INFO RECEIVED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21637815 ↗MalfunctionOct 4, 2023No Audible Alarm; No Audible Alarm
CUSTOMER STATES THAT THE PRODUCT 8645 FAILED TO ALARM WHILE IN USE WITH AN 8283 PAD. IT IS STATED THAT THE PATIENT STOOD UP, AND THE ALARM STAYED GREEN. THIS RESULTED IN A PATIENT FALL. THE CUSTOMER REPORTED THAT THERE WERE NO INJURIES RESULTING FROM THE FALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17873995 ↗InjuryApr 25, 2023Device Alarm System; Device Alarm System
WE RECEIVED A FDA MEDWATCH COMPLAINT ON PRODUCT # 8283 FROM UNKNOWN USER. IT IS STATED THAT A POSEY BED ALARM WAS PLACED ON A TRAUMA PATIENT AND THE ALARM DID NOT SOUND WHEN THE PATIENT TRIED TO EXIT THE BED. THIS RESULTED IN A FALL FROM THE BED. IT IS DESIGNATED AS A SERIOUS INJURY. THE REPORTER HAS DECIDED TO REMAIN ANONYMOUS. DATE OF THE REPORT IS (B)(6) 2023. REPORTED INITIALLY BY BRENDA AMMONETTE REG/COMP MANAGER. 920-279-7744 OR E-MAIL AT [email protected]. LOT # 2144T217. INFORMATION GIVEN WAS EXTREMELY LIMITED.
Patient problems: Fall
MAUDE report 16811821 ↗
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.