MAUDE Adverse Event Report: TIDI PRODUCTS, LLC POSEY ENCLOSURE BED; PATIENT BED WITH CANOPY/RESTRAINTS

Device Problem Mechanical Problem (1384)

Patient Problem Fall (1848)

Event Date 12/18/2022

Event Type  malfunction  

Event Description

Patient was lying against the side wall of the enclosure.The zipper at the bottom of bed (enclosed mattress compartment) separated.Patient slid through onto floor.

• Brand Name: POSEY ENCLOSURE BED
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 272 east deerpath road; suite 206; lake forest IL 60045
• MDR Report Key: 16111350
• MDR Text Key: 306798628
• Report Number: 16111350
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 98 KG