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

Model Number 8070

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the teeth on the right side panel was missing.It is unk when the issue was discovered.There was no pt incident or injury reported.

Manufacturer Narrative

Results: eval of the returned bed confirmed that the teeth on the right side panel were missing.Further eval revealed the following: the bottom stop and slider are missing on the head side leg, slider body open on the right side are missing on the right side panel; quarter inch tear on the left side netting; and a delaminated mattress envelope.All the issues listed were repaired and returned back to the customer for use.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: sokea peou ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4373543
• MDR Text Key: 5266568
• Report Number: 2020362-2014-00417
• 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: Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/01/2014

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: 11/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1