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

Model Number 8070

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage, Subdural (1894)

Event Date 05/31/2013

Event Type  Injury  

Event Description

Customer reported that they had a patient in the bed due to a pre-existing subdermal hemorrhage.The zipper underneath the panel zipper was not closed completely, the patient saw the gap in the zipper, opened the zipper and fell out.The patient hit her head and was taken to the emergency room for an x-ray which found a subdural hemorrhage.The patient was re-admitted to the rehab ctr for monitoring.The staff has had extensive training on confirming that all zippers are closed properly.No damage to the bed was reported.

Manufacturer Narrative

Customer maintains possession of the bed.Customer could not provide the serial number of the bed.The customer informed the distributor who inspected the bed after the event occurred and found no damages or issues with the bed.Customer reported that their distributor did a training of all personnel who come in contact or used the product to ensure that all zippers on the canopy are closed completely prior to leaving a patient inside the bed.This report is made based on the customer's initial report.Mfr reference file (b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: pam wampler, admin ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3951747
• MDR Text Key: 21243911
• Report Number: 2020362-2014-00229
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 07/02/2014
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR