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

Model Number 8070

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported multiple tears at the foot end of the canopy.Customer did not provide a date when the issue was discovered.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product found one element missing from the molding zipper of the left window and 8 inches of the material unraveling on the leg of the foot panel side.One element missing would allow the zipper to initially close, but can separate at the location of the missing element if sufficient pressure is applied.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(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. 16901. bodega 64; colonia ri o tijuana, 3ra. etapa; tijuana 2266 4; MX 22664
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4552834
• MDR Text Key: 5477050
• Report Number: 2020362-2015-00032
• 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: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• 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: 02/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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