MAUDE Adverse Event Report: PHILLIPS TELEPAK REMOTE MONITOR

Model Number EASI

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 08/10/2014

Event Type  malfunction  

Event Description

Pt states he felt a shock from the telepack monitor.No apparent malfunction, no loose or frayed wires noted, no red marks on pt's chest.

• Brand Name: TELEPAK REMOTE MONITOR
• Type of Device: TELEPAK REMOTE MONITOR
• Manufacturer (Section D): PHILLIPS; andover 01810
• MDR Report Key: 4031388
• MDR Text Key: 4849635
• Report Number: MW5037860
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EASI
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 115