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

Model Number 865351

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 09/12/2023

Event Type  Death  

Manufacturer Narrative

Section e reporter phone #: (b)(6).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.

Event Description

It was reported recently a patient expired.No additional details have been provided at this time and it is unclear if this event has already been reported.

Manufacturer Narrative

Per the response received via the customer the philips remote service engineer (rse) stated that the data for the second death mentioned is not made available despite asking for it.However, the rse confirmed that the customer wanted the data from the unit for review, and there was no implication of a fault.Based on the information provided in the case, the device was confirmed to be operating per specifications and no failure was identified.

Event Description

The customer reported that the mx40 patient wearable monitor was indicating the death on a patient wearing the device.

• Brand Name: MX40 PATIENT WEARABLE MONITOR
• Type of Device: TELEMETRY PATIENT 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: 17900515
• MDR Text Key: 325227037
• Report Number: 1218950-2023-00747
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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