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

Model Number 8060

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported panel b zipper is not catching correctly, possibly damage to the insert pin.Customer reported the panel a zipper is missing.Customer issue discovered during set-up but date was not provided.No pt incident or injury reported.

Manufacturer Narrative

Results: eval of the returned product confirmed the reported issue.There is an open slider body on the pt access of panel side b and a slider body missing on the pt access panel side a.Note: instructions for use state: never use the bed if a zipper slider is bent open or damaged and the zipper cannot be zipped completely closed.Remove the pt from the damaged bed and exchanged it for a posey bed in good working condition.Send the damaged posey bed in for repair.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3909882
• MDR Text Key: 4669215
• Report Number: 2020362-2014-00064
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• 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: 02/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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