MAUDE Adverse Event Report: J. T. POSEY CO. PERSONAL ALARM LOUD

Model Number 8202L

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Customer reported the alarm has power.However, it does not sound when the magnet pull cord is detached.The date when the issue was discovered is unknown.No patient incident or injury reported.

Manufacturer Narrative

Evaluation codes: results: evaluation of the returned product confirmed the reported issue and revealed that the unit has power.However, when the magnet is removed from the magnet plate, the alarm would sometimes sound and then it would stop.When tone select button is pressed, the unit would sometimes alarm to indicate the tone has been changed.However, it should alarm in this condition.The aqualert label shows evidence of moisture.(b)(4).

• Brand Name: PERSONAL ALARM LOUD
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA 91006
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary sergura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3770324
• MDR Text Key: 4444750
• Report Number: 2020362-2014-00031
• 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: 01/13/2014

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: 8202L
• Device Catalogue Number: 8202L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• 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: MAGNET, MODEL 8202L, LOT# UNK.