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

Model Number 8070

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

Customer reported the pt was in the bed, pushed through the netting of the canopy and the zipper did not hold together around the seams, allowing the pt to put his finger in the hole and unzip the canopy.Customer also reported the pt was using the bed, at the facility, for two weeks before this incident took place.Customer reported there was an injury but provided limited info.

Manufacturer Narrative

Product was requested to be returned for eval and has not been rec'd.Note: this report is based solely on the customer's reported issue.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3646870
• MDR Text Key: 4182133
• Report Number: 2020362-2013-00532
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2013

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: No
• 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