POSEY 8345 (UDI 10190676002082)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10190676002082), received between Sep 20, 2022 and Aug 23, 2024 — classified as 1 death, 11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024No Audible Alarm; No Audible Alarm

  UF/IMPORTER REPORT (B)(4). COMPLAINT REPORTED VIA THE FDA, SN (B)(6) ITEM # 8345, DISCONTINUED, ORDERED ON 5/17/22. COMPLAINT EVENT DATE WAS 5/17/24 EMAILED REPORT ON 7/26/24. IT WAS REPORTED A CHAIR ALARM DID NOT GO OFF AS DESIGNED. ALARM NOTED TO BE IN ON POSITION, BUT WHEN TESTED, DID NOT ACTIVATE WHEN SEAT BELT UNDONE, AS IT SHOULD. WHEN UNPLUGGED FROM SEAT BELT AND TURNED ON, ALARM SOUND WOULD WORK, BUT NOT WHEN PLUGGED IN. ALARM SWITCHED OUT, AND NEW ALARM WORKED WHEN ENGAGED AND PLUGGED IN AND SEAT BELT UNDONE, LEADING US TO SUSPECT PROBLEM WITH JACK PORT. ALARM PULLED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20054132 ↗
• MalfunctionJul 9, 2024No Audible Alarm; No Audible Alarm

  SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 19702484 ↗
• MalfunctionMar 21, 2024No Audible Alarm; No Audible Alarm

  TM REPORTED COMPLAINT VIA EMAIL. ISSUE OCCURRED WITH SN (B)(6) (EXPIRED ALARM), BUT RESULTED WITH A PATIENT INCIDENT/INJURY. PER THE TM: SITTER ELITE ALARM WITH THE 8399L-HEADSTART CHAIR BELT. ALARM DID NOT GO OFF WHEN PATIENT SELF-RELEASED THE HEADSTART BELT. PATIENT FELL AT 3 PM TODAY AND IS ON THEIR WAY TO HAVE CT SCAN TO IDENTIFY ANY INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 18951378 ↗
• MalfunctionJan 16, 2024No Audible Alarm; Fail-Safe Problem; No Audible Alarm; Fail-Safe Problem

  ALARM DOES NOT PROPERLY SOUND EVEN WITH ACTIVE POWER. MAGNET CORD WAS TESTED AND CONFIRMED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522188 ↗
• MalfunctionNov 16, 2023Intermittent Loss of Power; Intermittent Loss of Power

  CUSTOMER CONTACTED VIA PHONE STATING THAT THE ALARM WILL CONTINUE TO ALARM INTERMITTENTLY. ISSUE ALSO OCCURS WHEN THE ALARM IS TURNED OFF. INITIAL TROUBLESHOOT VIA PHONE CORRECTED ISSUE, BUT CONTINUED ON WITHIN THE HOUR SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18154606 ↗
• MalfunctionNov 1, 2023Low Audible Alarm; Low Audible Alarm

  CUSTOMER REPORTED COMPLAINT VIA PHONE CALL. PATIENT FALL OCCURRED WITH THE ALARM, VOLUME WAS QUIET UPON SOUNDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052166 ↗
• MalfunctionMay 19, 2023No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED COMPLAINT VIA PHONE. ALARM WILL NOT POWER ON, TROUBLESHOOTING WITH NEW BATTERIES DID NOT RESOLVE ERROR, UNIT APPEARS TO HAVE NO DAMAGE. SN (B)(6). PLEASE ADVISE WHEN QA EVALUATION IS COMPLETE. CALLED IN BY (B)6). THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961392 ↗
• DeathOct 27, 2022No Audible Alarm; No Audible Alarm

  TIDI PRODUCTS RECEIVED A LEGAL SUMMONS REGARDING A PATIENT DEATH AT SALEM REGIONAL MEDICAL CENTER WHILE UTILIZING POSEY SITTER ELITE ITEM #8345. SUMMONS NOTED INCORRECT SITTER ELITE MODEL NUMBER, HOWEVER THE MODEL NUMBER WAS CONFIRMED BY SALEM REGIONAL MEDICAL CENTER ATTORNEY. PATIENT WAS UNDER FALLS MANAGEMENT CARE PLAN, WHICH INCLUDED THE SITTER ELITE ALARM. A FALL WAS REPORTED THAT RESULTED IN AN INTRACRANIAL HEMORRHAGE THAT RESULTED IN A PATIENT DEATH. IN THE SUMMONS, IT INDICATES THAT THE ALARM DID NOT SOUND.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15679811 ↗
• MalfunctionSep 23, 2022Communication or Transmission Problem; Communication or Transmission Problem

  ON (B)(6) 2022 BD1 THE CUSTOMER CONTACTED US VIA PHONE CALL. CUSTOMER STATES THAT THE ALARM WILL NOT TRIGGER NURSE CALL SYSTEM AT THE NURSE STATION. CUSTOMER SAID THEY TIRED A NEW UNIT WITH WHERE THIS ALARM WAS AND IT WORKED. NO APPARENT DAMAGE TO THE UNIT ON THE NC PORT OR BATTERY COMPARTMENT. SN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470317 ↗
• MalfunctionSep 20, 2022No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED ONE ALARM VIA EMAIL. UNIT DOES NOT POWER ON, NO SIGNS OF CORROSION OR DAMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460214 ↗
• MalfunctionSep 20, 2022No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED AN ALARM VIA EMAIL THAT THE ALARM DOES NOT MAKE SOUND. NO PHYSICAL DAMAGE OR MUTE MODE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457778 ↗
• MalfunctionSep 20, 2022No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED AN ALARM VIA EMAIL THAT THE ALARM DOES NOT MAKE SOUND. NO PHYSICAL DAMAGE OR MUTE MODE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457328 ↗