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

Model Number 8070

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Customer reported while a pt was occupying the canopy bed, the pt was able to unzip the side panel and fell out.No serious injury was reported.

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.Customer did not provide the reported bed serial number.Note: this report is submitted based on the customers reported issue statement.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J.T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave ferrocarril no. 16901 bodega 64; colonia rio tijuana, 3ra etapa; tijuana 2266 4; MX 22664
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4001333
• MDR Text Key: 4705508
• Report Number: 2020362-2014-00244
• 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: 06/19/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/21/2014
• 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 Age: 45 YR