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

Model Number 8070

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported that they discovered during set up of the bed that the pull tab, is missing from both the left and right side panels.No pt incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product did not confirm the reported issue; however, the right side window molding zipper has one zipper element missing.Panel side head the left leg cover zipper insert pin and slider is missing.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J.T. POSEY COMPANY; arcadia CA
• Manufacturer Contact: pam wampler, admin ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4001335
• MDR Text Key: 4689710
• Report Number: 2020362-2014-00243
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• 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
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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