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

Model Number 8070

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

The customer reported that while a pt was inside the canopy, the pt pushed through the zipper and fell to the floor.No pt injury was reported.The customer would not provided any further pt info.

Manufacturer Narrative

Results: eval of the returned bed canopy found the left side window zipper slider pull tab had broken free and the "ring" that connects the pull tab to the quick release buckle had been looped through the crown of the slider where the pull tab should connect.The slider body was found to be open and out of mfg specifications, which would contribute to preventing the slider from properly engaging the zipper teeth.Additionally, the pull tab and crown of the head side leg zipper were missing.The canopy itself was found to be in good condition and well maintained.The cause of the open slider body and missing pull tab is likely excessive force being applied to the pull tab.The force required to cause this type of slider body to open is approximately the same as the force required to pull off the pull tab.The observed "looping" of the ring through the slider crown is an unauthorized modification of the device.Posey warns that unauthorized repairs increase the risk of product failure, and that use of an unrepaired canopy may result in serious injury to the pt or caregiver.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO. DE R.L. DE C.V. AVE.; ferrocarril no. 16901; bodega tijuana 2266 4; MX 22664
• Manufacturer Contact: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4148387
• MDR Text Key: 4765681
• Report Number: 2020362-2014-00322
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2014

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: 09/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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