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

Model Number 8060

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Customer reported zipper damage on panel side b.Customer did not provide a date when issue was discovered.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product found an open slider body on panel side a and the mattress envelope is delaminated.There is also 9 inch broken stitches and broken elastic on panel side d.(b)(4).

• Brand Name: POSEY BED
• Type of Device: OYS
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA 91006
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3881057
• MDR Text Key: 4509458
• Report Number: 2020362-2014-00130
• 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: 02/28/2014

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: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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