MAUDE Adverse Event Report: J. T. POSEY CO. 8345

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 alarm only sounds in the pt's room and not at the nurse's station.Batteries have been replaced with a new supply and no visible damage reported.Customer could not provide a date when found.No pt incident or injury reported.

Manufacturer Narrative

Results: eval of the returned product confirmed the reported issue; unit sounds but the tight does not come on at the nurse call test fixture.Unit passes all other functional tests.No physical damage found to the unit.(b)(4).

• Brand Name: 8345
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: pam wampler, admin ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3847721
• MDR Text Key: 4408097
• Report Number: 2020362-2014-00090
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/17/2014

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: 03/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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 # UNK