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

Model Number 8070

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

Customer reported damage to the zipper located on the left side panel.Customer did not know the date this was found.No pt incident or injury was reported.

Manufacturer Narrative

Results: eval of the returned product on the left side window zipper slider body is open.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): POSEY, S. DE R.L. DE CV. AVE. FERROCARRIL; no. 6901 bodega 64, col rio; tijuana 3ra etapa; tijuana C.P. 226; MX C.P. 2266
• Manufacturer Contact: pam wampler, admin ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3904711
• MDR Text Key: 4514741
• Report Number: 2020362-2014-00195
• 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: 05/06/2014

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: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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