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 Date 09/20/2014

Event Type  malfunction  

Event Description

Customer reported that they had placed a very tall male patient inside of the canopy.The patient sat sideways in the bed and kicked the side panel repeatedly causing the teeth to separate on the zipper, allowing the patient to get out of the canopy.No patient injury was reported.

Manufacturer Narrative

Product has been requested to be returned but has not been received to date.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO. DE R.L. DE C.V.; ave. ferrocarril no. 16901; bodega, tijuana 2266 4; MX 22664
• Manufacturer Contact: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4208910
• MDR Text Key: 4968271
• Report Number: 2020362-2014-00347
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/22/2014

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: 09/22/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2012
• 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