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

Model Number 8345

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the nurse call receptacle on the alarm is damaged.The issue was discovered during setup, but the date is unknown.No patient incident or injury reported.

Manufacturer Narrative

Results: evaluation of the returned product confirmed the report issued.The unit nurse call receptacle outer housing is damaged, but the internal mechanism is still intact.Although the nurse call receptacle is damaged, unit can still secure the nurse call cable.However, the red led at the nurse call test fixture turns on and off when the nurse call cable is moved.Also, a rattling sound is heard coming from inside of the unit.(b)(4).

• Brand Name: POSEY SITTER ELITE
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3904678
• MDR Text Key: 4678573
• Report Number: 2020362-2014-00192
• 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: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: NURSE CALL CABLE, MODEL 8282, LOT# UNKNOWN