POSEY 3060MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190676002600), received between Nov 8, 2023 and Dec 6, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER REPORTING A COMPLAINT ON PRODUCT 3060. (B)(6). CUSTOMER STATES THAT PATIENTS CAN UNDO THE STRAPS AND CLIP ON THE 3060 VEST. THE PATIENT THEN IS ABLE TO GET OUT OF BED UNSUPERVISED. IT IS NOTED THAT PRODUCT IS NOT AVAILABLE FOR RETURN FOR EVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871116 ↗
• MalfunctionDec 6, 2024Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT PART 3060. (B)(6). CUSTOMER STATES THAT THE PATIENT WAS ABLE TO UNDO THE CLIPS OF THE VEST BY LEANING OVER THE SIDE OF THE VEST & THEN REACHING UNDER THE BED TO UNCLIP THE VEST. THE PATIENT WAS THEN ABLE TO GET OUT OF BED. REPORT INDICATES THE PRODUCT IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869933 ↗
• MalfunctionOct 16, 2024Break; Break

  UF/IMPORTER REPORT #: (B)(4). PATIENT BECAME AGITATED AND ATTEMPTED TO GET OUT OF BED AND PUNCHED THREE TIMES AT A NURSE, STRIKING THE NURSE AT THE THIRD ATTEMPT. THE PATIENT WAS PLACED IN BILATERAL SOFT WRIST RESTRAINTS AND A SAFETY VEST RESTRAINT. MANY HOURS LATER, THE PATIENT BECAME AGITATED ONCE AGAIN AND SUCCESSFULLY PULLED OUT THE BILATERAL SOFT WRIST RESTRAINTS AND RIPPED THE FABRIC OF THE SAFETY VEST TRYING TO GET OUT OF BED. THERE WAS NO STAFF INJURY OR VIOLENCE TOWARDS THE TEAM WITH THIS SECOND EVENT, NOR DID THE PATIENT SUFFER ANY INJURIES. NURSING TEAM WAS CONCERNED ABOUT THE FABRIC TEARS IN THE SAFETY VEST RESTRAINT AND REQUESTED THE MANUFACTURER REVIEW THE SAFETY VEST RESTRAINT AND WHY THE FABRIC WAS ABLE TO RIP APART. ITEM 3060M LOT# 4046T011.

  Patient problems: Insufficient Information

  MAUDE report 20461707 ↗
• MalfunctionNov 21, 2023Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER IS REPORTING A COMPLAINT ON ROLL VEST 3060M. CUSTOMER STATES THAT THE STRAP MATERIAL IS TOO LONG FOR THE ROLL VESTS. THE LENGTH MAKES IT EASY FOR THE PATIENTS TO UNCLIP THE BUCKLE AND REMOVE THE RESTRAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188077 ↗
• MalfunctionNov 8, 2023Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT # 3060M. THE CUSTOMER STATES THAT PATIENT CAN UNBUCKLE THE ROLL VESTS BY THEMSELVES. THIS HAS TAKEN PLACE IN MULTIPLE INSTANCES. LIKELY THEY WILL NOT BE SENDING THE PRODUCT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097202 ↗