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 Problem Cardiac Arrest (1762)

Event Date 05/18/2023

Event Type  Death  

Event Description

The customer reported the death of a 68-year-old post-op repair/replacement of an ascending aortic aneurysm.The surgery took place on (b)(6) 2023, the patient was admitted to the intensive care unit (icu) thereafter and on (b)(6) 2023, the patient started to experience nausea, vomiting and fever, although hemodynamics were reportedly still stable.At approximately 04:00 on (b)(6) 2023, the nurse noticed abnormal trace on the central station and subsequently went to the patient¿s room and found the patient in cardiac arrest.The on-call resuscitator was called but unfortunately the patient was declared dead at 06:00.The patient information center ix, catalog item 866389, serial number (b)(6), in use during this event was reported in mfr report number 1218950-2023-00417.

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.

Manufacturer Narrative

The following functional tests were performed: the philips remote service engineer (rse) extracted and analyzed the logs, and the device was working as designed.The complaint was escalated to the product support engineer (pse) for technical investigation and the results indicate for timepoint of (b)(6) 2023 at around 04:30 a.M., the tel11 of bed label 441 had cardiac alerts which were silenced at the patient information center ix (pic ix).The mx40 was associated to the picix from 03:52 a.M.Until 07:10.Mx40 was sending alarms to the pic ix until an ecg leads off condition occurred.The audit log shows that premature ventricular contraction (pvc) alarms were being provided until the ecg leads off condition occurred.Also note that ecg leads off was set as a !!! red technical inop alarm.No further ecg related physiological alarms would be provided until the ecg leads off condition was resolved.The mx40 was functioning as intended.The reported problem was not confirmed.Information was provided to the customer to resolve the issue.

• 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: 18023760
• MDR Text Key: 326789087
• Report Number: 1218950-2023-00818
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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