MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILLIPS MX40 TELEMETRY MONITOR; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Problems Break (1069); Corroded (1131); Material Discolored (1170); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

A review of the phillips telemetry monitoring took place.Phillips telemetry monitor pack, model mx40, have had issues with contact corrosion and discoloration, damage or missing gaskets noted corrosion on pack lead set contact pins and subsequent function problems such as drop out and poor pin contact.Fda safety report id # (b)(4).

• Brand Name: PHILLIPS MX40 TELEMETRY MONITOR
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 10777807
• MDR Text Key: 214542136
• Report Number: MW5097611
• Device Sequence Number: 1
• Product Code: DSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR