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

Model Number 8070

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported that a zipper is missing from the canopy, but wa unable to provide the specific location.The date the issue was discovered is unknown.No patient incident or injury was noted.

Manufacturer Narrative

Results: evaluation of the returned product did not confirm the reported issue that the canopy has a missing zipper.However, the patient access window side right, zipper slider body is open.No other canopy issue was made.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 1601. bodega 64; colonia rio tijuana, 3ra. etapa; tijuana ; MX
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4148392
• MDR Text Key: 20860218
• Report Number: 2020362-2014-00323
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• 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: 08/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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