MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PHILIPS INTELLIVUE MP5SC SPOTCHECK MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number INTELLIVUE PATIENT MONITOR MP5SC

Device Problems Fire (1245); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2023

Event Type  Injury  

Event Description

Monitor was on stand-by and plugged into outlet when it suddenly started smoking then burst into flames.

• Brand Name: PHILIPS INTELLIVUE MP5SC SPOTCHECK MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 16843145
• MDR Text Key: 314272082
• Report Number: 16843145
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/27/2023,04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: INTELLIVUE PATIENT MONITOR MP5SC
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2023
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Life Threatening