MAUDE Adverse Event Report: POSEY PATIENT BED WITH CANOPY/RESTRAINTS

Model Number POSEY 8060 NON-LNTEGR CANOPY

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2017

Event Type  malfunction  

Event Description

Found on the floor yesterday morning.Zipper was open.Per (b)(6), he thinks the patient fell due to the equipment not being zipped up.There were no patient injuries an no medical attention required.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PATIENT BED WITH CANOPY/RESTRAINTS
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY
• MDR Report Key: 17534903
• MDR Text Key: 321163163
• Report Number: MW5141803
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018

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?: No
• Device Model Number: POSEY 8060 NON-LNTEGR CANOPY
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 61 YR