POSEY 8345 (REF 2370)Recalls & reported problems
Posey Products, LLC · POSEY SITTER ELITE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10190676005489), received between Nov 6, 2024 and Mar 18, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (9 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
Most reported problems
Device problems
- No Audible Alarm9
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026No Audible Alarm
CUSTOMER REPORTED COMPLAINT INVOLVING A PATIENT FALL. LIMITED INFORMATION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24631993 ↗MalfunctionSep 17, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED VIA EMAIL THAT 2 OF 8345 ALARMS ARE NOT WORKING PROPERLY. THE NURSE CALL CORD IS EASILY REMOVED WITHOUT RESISTANT/FALLS OUT. WHEN THE CHAIR ALARM GOES OFF, IT DOES NOT TRIGGER THE ROOM BED EXIT ALARM. BOTH UNITS ARE DAMAGED AT THE NURSE CALL CONNECTION. THE INTERNAL PLASTIC HOUSING WAS BROKEN MAKING THE CONNECTION POINT WEAK AND/OR NONEXISTENT. NO PATIENT INJURY. SN: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076824 ↗MalfunctionSep 17, 2025No Audible Alarm; No Audible Alarm
CUSTOMER RERPOTED VIA EMAIL THAT 2 OF 8345 ALARMS ARE NOT WORKING PROPERLY. THE NURSE CALL CORD IS EASILY REMOVED WITHOUT RESISTANT/FALLS OUT. WHEN THE CHAIR ALARM GOES OFF, IT DOES NOT TRIGGER THE ROOM BED EXIT ALARM. BOTH UNITS ARE DAMAGED AT THE NURSE CALL CONNECTION. THE INTERNAL PLASTIC HOUSING WAS BROKEN MAKING THE CONNECTION POINT WEAK AND/OR NONEXISTENT. NO PATIENT INJURY. SN: (B)(6) AND (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076790 ↗MalfunctionJun 18, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 1 OF 8345 SITTER ELITE NOT WORKING PROPERLY. WHEN PATIENT IS ON SENSOR THE ALARM WILL ALERT. HOWEVER WHEN GETTING OFF THE SENSOR THE ALARM WILL NOT ALERT / NOTIFY STAFF. STAFF HAD CHANGED THE SENSORS A FEW TIMES AND THE ALARM WILL CONTINUE TO ALARM. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283286 ↗MalfunctionApr 28, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED COMPLAINT VIA PHONE A UNIT THAT IS NOT SOUNDING. REPORTED SERIAL NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922018 ↗MalfunctionFeb 11, 2025No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED ALARM DOES NOT MAKE SOUND, MISSING BATTERY COVER. SN (B)(6). THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21358118 ↗MalfunctionDec 3, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED TWO SITTER ELITE ALARMS NOT WORKING AND OR DAMAGED. NO PATIENT INJURY OR INCIDENT. SN: (B)(6), STUCK IN SUSPEND MODE. SN: (B)(6), DAMAGED WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833757 ↗MalfunctionNov 26, 2024No Audible Alarm; No Audible Alarm
CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT 8345. CUSTOMER STATES THAT A PATIENT INCIDENT OCCURED WITH THIS PRODUCT. S/N (B)(6) SITTER ELITE, SEATBELT WAS USED WITH THE 8345 ALARM AND THE PATIENT WAS ABLE TO STAND UP ON THEIR OWN WITHOUT THE ALARM SOUNDING. IT TOOK SEVERAL ATTEMPTS TO GET THE ALARM TO SOUND ACTIVELY. MEDWATCH # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20786893 ↗MalfunctionNov 6, 2024No Audible Alarm; No Audible Alarm
CUSTOMER REPORTED 12 ALARMS NOT WORKING PROPERLY. NO PATIENT INJURY OR INCIDENT. NEW BATTERIES WERE REPLACED ALL AT ONCE, SAME BRAND. PICTURES RECEIVED, SOME SHOWS PHYSICAL DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20624885 ↗
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- Medline MDT8450YMedline Industries, Inc. · MONITOR, BED PATIENT29 reports
- POSEY 8309ELPosey Products, LLC · Monitor, Bed Patient2 deaths19 reports
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- POSEY 8645WLPosey Products, LLC · Monitor, Bed Patient17 reports
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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