MAUDE Adverse Event Report: LIFEWATCH SERVICES INC. LIFEWATCH MCT 1 LEADPATCH (MCT 1LP); DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Scarring (2061); Swelling (2091); Burn, Thermal (2530)

Event Date 03/18/2018

Event Type  Injury  

Event Description

The patient states that she was sleeping when the heart monitor began beeping.She said that her son came into her room to check on her right after hearing the beeping.The patient reports that she experienced topical burns, swelling, and scarring as a result of the incident.The patient also has pictures regarding the event if needed.

• Brand Name: LIFEWATCH MCT 1 LEADPATCH (MCT 1LP)
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): LIFEWATCH SERVICES INC.
• MDR Report Key: 7424838
• MDR Text Key: 105384980
• Report Number: MW5076427
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 96