MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 865350

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Event Description

This telemetry box malfunctioned per the nurse caring for the patient in this room.She stated the box made a loud noise, then shut off and started smoking.The patient was not affected by this.The floor called us, and we brought another box up.Cts then came in and took this box and programmed a backup box for us.The battery pack in this box has turned black around one of the terminals and had melted some.This box has been sent to sage for repair.

• Brand Name: MX40
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9626854
• MDR Text Key: 176235751
• Report Number: 9626854
• Device Sequence Number: 1
• Product Code: MHX
• 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: 01/21/2020

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: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2020
• Device Age: 9 YR
• Date Report to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1