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

Model Number 8060

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported panel a has a damaged zipper.Customer did not provide a date when the issue was discovered.No patient incident or injury was reported.

Manufacturer Narrative

Evaluation of the returned product found that the slider body is open on the patient access of both panel side a and b.The pull tab is missing on the iv port of window side b.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3856458
• MDR Text Key: 4621638
• Report Number: 2020362-2014-00153
• 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: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• 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
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2006
• 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