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

Model Number 8070

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the pull tab is missing on the u panel of the right side and the slider is damaged on the u panel of the left side.Customer did not provide a date when the issue was discovered.No pt injury or incident reported.

Manufacturer Narrative

Eval: results - eval of the returned product found a broken slider body on the left pt access window which does not allow correct element closure.In addition, a pull tab is missing on the right window and there is frayed nylon on panel side a and b.This canopy has been in service for over 4 yrs.(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 rio tijuana, 3ra etapa; tijuana 2266 4; MX 22664
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4451380
• MDR Text Key: 5383114
• Report Number: 2020362-2015-00018
• 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: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• 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: 01/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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