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

Model Number 8070

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported that the zipper has come apart at the panel.Also, the zipper is pulling apart at the teeth located at the head end panel.The issue was discovered during setup, but the date of the event is unknown.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product confirmed the reported issue.The patient access window side left has an open slider body.Also, a slider body is stuck and the pull tab is broken on the perimieter guard zipper.There are multiple damages to the canopy.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 6901 bodega 64,; col rio tijuana 3ra etapa; tijuana 2266 4; MX 22664
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3869021
• MDR Text Key: 4458724
• Report Number: 2020362-2014-00171
• 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: 04/01/2014

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: 04/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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