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); Perforation (2001); Insufficient Information (4580)

Event Date 09/05/2023

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

The customer reported a patient on the telemetry ward passed away on (b)(6) 2023.The patient was probably on telemetry for about five days before their death.

Manufacturer Narrative

The remote support engineer (rse) pulled the audit logs of the system for the review to determine the cause of the reported issue.Based on the information available and the testing conducted, the cause of the reported problem was a user error in patient discharge.The reported problem was not confirmed.The engineer provided their analysis findings.The mx40 patient wearable monitor has not caused or contributed to the reported issue, as the device was working as intended.

Manufacturer Narrative

The patient information center ix in use during this event was reported in mfr report number 1218950-2023-00670.

• 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: 17900512
• MDR Text Key: 325226352
• Report Number: 1218950-2023-00746
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,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 Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2019
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 1 KG