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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEOLEAD; ELECTRODE, ELECTROCARDIOGRAPH

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PHILIPS MEDICAL SYSTEMS NEOLEAD; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Model Number 989803183101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Tears (2516)
Event Date 03/26/2020
Event Type  malfunction  
Event Description
Different cardio respiratory leads than our usually stocked cardio respiratory leads were on infant and when removed took a piece of infants skin off with it.Our usually stocked leads are neotrode and the replacement leads were philips neolead.
 
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Brand Name
NEOLEAD
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key9928311
MDR Text Key186554322
Report Number9928311
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/30/2020
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 Other
Device Model Number989803183101
Device Catalogue Number989803183101
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2020
Event Location Hospital
Date Report to Manufacturer04/06/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2020
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age365 DA
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