MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 WLAN

Model Number 865352

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Fibrillation (2130)

Event Date 02/22/2024

Event Type  Death  

Event Description

It was reported that the system did not recognize 10:23 red event as a red alarm.A patient death due to ventricular fibrillation was reported.The device was in use on a patient.There was a report of patient or user harm.

Manufacturer Narrative

E1: reporter institution phone number (b)(6).E1: reporter phone # (b)(6).A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

A philips clinical specialist & product support engineer has reviewed the data including the audit logs.The findings are as follows: this patient had an active asystole alarm from (b)(6) 09:57:58 and continued until the ecg leads off generated at 10:43:34.The audit log reflects the asystole alarm 09:57:58, many cannot analyze ecg alarms at 10:24:55, 10:25:51, 10:28:46, 10:29:21, 10:29:31, 10:29:34 during the time in question which may decrease the effectiveness of arrhythmia monitoring.This is described in the st/ar application note: during this inop/technical condition, the arrhythmia analysis continues and an alarm will be announced if an alarm condition is met.Since the cannot analyze ecg inop/technical alarm indicates that the effectiveness of the arrhythmia monitoring for the patient is compromised, a quick response to this alarm is important.Multiple instances are also seen where the staff interacted with the pic to capture the 12 lead several different times, but no one acknowledged the asystole alarm from 09:57:58.The asystole alarm ended at 11:11:07 when the device was no longer connected to the pic ix.Based on the information provided to philips, it was determined that there was no product malfunction and the device was functioning as intended.The reported issue was caused by user error.

Event Description

It was reported that the system did not recognize 10:23 red event as a red alarm.A patient death due to ventricular fibrillation was reported.The device was in use on a patient.There was a report of patient or user harm.

• Brand Name: INTELLIVUE MX40 WLAN
• Type of Device: INTELLIVUE MX40 WLAN
• 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: 18815348
• MDR Text Key: 336624075
• Report Number: 1218950-2024-00150
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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: 63 YR
• Patient Sex: Male