MAUDE Adverse Event Report: J. T. POSEY CO. POSEY BED

Model Number 8070

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Distributor reported that their customer had a patient with pre-existing head trauma inside of the canopy.The medical staff noticed that the patient was kicking on the window and the zipper opened up.The medical staff immediately removed the patient from the canopy.When the distributor inspected the canopy, they noticed that the zipper pull tab is broken off of the zipper and when the zipper is zipped, the zipper opens back up.Distributor did not know the date of event.No patient incident or injury was reported.

Manufacturer Narrative

Distributor is in process of returning the canopy.This report is made based solely on the information provided by the distributor.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO. DE RL DE CV; ave ferrocarril no 16901; bodega tijuana 2266 4; MX 22664
• Manufacturer Contact: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4355794
• MDR Text Key: 5141269
• Report Number: 2020362-2014-00398
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2014

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
• Device Operator: Health Professional
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1