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

Model Number 8070

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Customer reported a broken zipper and damage to the teeth on the end foot panel of the canopy.Customer could not provide the date when found.No pt incident or injury was reported.

Manufacturer Narrative

Results: eval of the returned canopy found one zipper element is missing on the right side pt window.Foot and head tube rail slider body zippers are open.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; de r. l. de c.v. ave. ferrocarril no. 16901; bodega tijuana 2266 4; MX 22664
• Manufacturer Contact: pam wampler, administrator ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3855622
• MDR Text Key: 19967559
• Report Number: 2020362-2014-00148
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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