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

Model Number 8070

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Results: evaluation of the returned product confirmed the reported issue and revealed that the panel side right, mattress envelope is delaminated.Also, the patient access window side left, has one tooth element missing.(b)(4).

Event Description

Customer reported zipper damage to the right side panel.The issue was discovered during setup, but the date is unknown.No patient incident or injury was reported.

• 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, cp 2266 4; MX 22664
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3869036
• MDR Text Key: 19534162
• Report Number: 2020362-2014-00165
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• 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: 04/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• 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