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

Customer reported that the resident fell out of a posey bed.When the resident was placed in the bed, the zippers an safety clips were secured.Customer reported that upon video surveillance, the resident is seen leaning against the inside of the mesh on the left side of the bed.After several minutes, she appears to get a small gap in the zipper, and then proceeds to rip the zipper completely open.She fell out of the bed a short time later.The pt did not suffer any injures.Customer did not provide the pt identifier, weight or exact day of event.

Manufacturer Narrative

Evaluation found that the left side pt access zipper slider body was found to be open and out of manufacturing specifications, which can contribute to preventing the slider from properly engaging the zipper teeth.In areas where the slider is able to engage the zipper teeth, the zipper chain cannot be opened.The cause of the open slider body and missing pull tab is likely excessive force being applied to the pull tab.The left side window zipper slider pull tab is missing and the key-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 observed "looping" of the ring through the slider crown is an unauthorized modification of the device.There are two holes in the fabric along the outside mattress seam and inside of the bolster bag.One of the right side soft-rail buckles is missing.A broken tooth was found at the right side head cross-bar seam.There was no tooth damage along the pt access panel.Delamination of the mattress compartment was observed.(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 CP 2 2664; MX CP 22664
• Manufacturer Contact: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4180366
• MDR Text Key: 18035758
• Report Number: 2020362-2014-00332
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

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: 09/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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
• Patient Age: 6 YR