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

Model Number 8060

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

The distributor ordered a replacement window for the canopy and was advised that the entire canopy needed to be returned.No product damages or malfunctions were reported by the distributor.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned canopy found that on both panel a & b windows, the zipper slider bodies are bent open.Window side a, the insert pin is missing.Panel side a has broken stitches on the connecting zipper.Note: posey instructions for use has a warning statement: never try to rip a panel open as they may damage the access panel or the zipper slider by bending it open.Never use the bed if a zipper slider is bent open or damaged, as this may prevent the zipper from closing securely.Never leave the patient's bedside until all access panel zippers are securely closed.Test the entire length of each zipper by pressing against the panel near the zipper to make sure it is securely closed and the access panel will not open when pressure is applied.Inspect zipper coils for any kinks or misalignment.Test that all zippers open easily and close securely and there are no gaps or openings when pressure is applied along the entire length of each zipper.Always use zipper pull-tabs and ensure that zippers are fully closed.

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: pam wampler, prod surv admin ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3868508
• MDR Text Key: 4589179
• Report Number: 2020362-2014-00180
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113355
• 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: 03/31/2014

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: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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