MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40; INTELLIVUE MX40

Model Number MX40

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 06/18/2018

Event Type  malfunction  

Event Description

The patient states that he felt a sudden burn on left upper chest skin, immediately removed telemetry electrode.New wound present where electrode was.Telemetery box including battery and leads sequestered and sent to biomed.Biomed contacting phillips for evaluation.Electrodes were not saved.

• Brand Name: MX40
• Type of Device: INTELLIVUE MX40
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 7681177
• MDR Text Key: 113757187
• Report Number: 7681177
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00884838030350
• UDI-Public: 884838030350
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX40
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2018
• Date Report to Manufacturer: 07/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15695 DA