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U.S. Department of Health and Human Services

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

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LIFEWATCH SERVICES INC. LIFEWATCH MCT 1 LEADPATCH (MCT 1LP) DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
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.

 
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Brand NameLIFEWATCH MCT 1 LEADPATCH (MCT 1LP)
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
LIFEWATCH SERVICES INC.
MDR Report Key7424838
MDR Text Key105384980
Report NumberMW5076427
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received04/11/2018
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
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/11/2018 Patient Sequence Number: 1
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