MAUDE Adverse Event Report: J. T. POSEY CO. POSEY SITTER ELITE

Model Number 8345

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported that the specific alarm product issue is unknown.The date of the event is unknown.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product revealed that the nurse call receptacle appears to be in good condition, but when the nurse call cable is inserted into the nurse call receptacle and wiggled, the red led at the nurse call test fixture toggles on and off.Visual findings observed a crack on the dust cover outside of the battery compartment.

• Brand Name: POSEY SITTER ELITE
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4134196
• MDR Text Key: 17630487
• Report Number: 2020362-2014-00319
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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