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

Model Number 8070

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The distributor reported the right side retaining box is missing and the teeth and insert pin is damaged.This was discovered during setup in their warehouse and no patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product did not confirm the reported issue.The zipper slider body is open on the left patient access window.Right side window zipper pull tab is missing and there are broken stitches on the top ridge.(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 ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3823733
• MDR Text Key: 19923780
• Report Number: 2020362-2014-00055
• 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: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• 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: 01/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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