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

Model Number 8060

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported the teeth on the right side panel are damaged, therefore, unable to zip the panel.The date when the issue was discovered is unk.No pt incident or injury was reported.

Manufacturer Narrative

Results: eval of the returned product confirmed the reported issue.Eval revealed that the pt access, panel side a, zipper slider body is open.Also, panel side d, has an elastic tear.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3745188
• MDR Text Key: 4225719
• Report Number: 2020362-2014-00028
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113355
• 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: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2006
• 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