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

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.

• Brand Name: NEOLEAD
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9928311
• MDR Text Key: 186554322
• Report Number: 9928311
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 989803183101
• Device Catalogue Number: 989803183101
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 365 DA