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

Model Number 8070

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Customer reported damage to the teeth on the right side panel, damage to the pull tab located on the right side head post and on the pull tab.

Manufacturer Narrative

Results: evaluation of the returned product found on the left side molding zipper element missing.Right side window perimeter guard zipper pull tab is broken.(b)(4).

• Brand Name: POSEY BED
• Type of Device: OYS
• Manufacturer (Section D): J. T. POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer (Section G): J. T. POSEY COMPANY; de r.l. de c.v. ave; ferrocarril no. 16901; bodega tijuana 2266 4; MX 22664
• Manufacturer Contact: pam wampler, administrator ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3815856
• MDR Text Key: 4450526
• Report Number: 2020362-2014-00107
• 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: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• 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: 03/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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