MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 PATIENT WEARABLE MONITOR

Model Number 865351

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporter phone b)(6).Reporting institution phone (b)(6).

Event Description

It was reported alarms were not generated and the telemetry patient passed away.

• Brand Name: MX40 PATIENT WEARABLE MONITOR
• Type of Device: MX40 PATIENT WEARABLE MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18804624
• MDR Text Key: 336505719
• Report Number: 1218950-2024-00145
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Date Manufacturer Received: 02/01/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death