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

The distributor reported damage to the zippers located at the right side panel and head panel, the parts that are damaged are the slider, teeth and insert pin.The right side zipper was cut.This was discovered during set up in their ware house and no patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product found the zipper slider body is open on the patient access window.There is a 1 inch tear in the netting.On the head side panel the zipper stuck.Left side window pull tab is missing on the patient access zipper and iv port zipper is stuck.Open slider on the perimeter guard zipper.Foot side panel left leg cover zipper tape is cut and the insert pin is missing.(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: 3823722
• MDR Text Key: 21446247
• Report Number: 2020362-2014-00057
• 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: 01/24/2014

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: 02/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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