MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ

Model Number 865351

Device Problem Device Alarm System (1012)

Patient Problem Tachycardia (2095)

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.Reporting address state: (b)(6).

Event Description

The customer reported that the mx40 device failed to alarm on (b)(6) 2024 at 5:30 am on bed tel6.This resulted in a patient death.A philips remote service engineer (rse) spoke with the customer and the customer alleged that the device failed to alarm on (b)(6) 2024 at 5:30 am on bed tel6 and this resulted in a patient death.As per case notes, the customer¿s device was rebooted the day prior to the event.A philips field service engineer (fse) went to the customer site and retrieved logs, windows logs, watchdog dump, clinical audit trail and mx40 logs.A philips product specialist engineer (pse) and a clinical application specialist (cas) reviewed the audit logs provided by the customer.The results of audit log analysis are as following: there were tachycardia alarms being generated and played around 05:30 several times on february 1.After the alarms played on the pic ccu_tel host, the alarm was acknowledged on the ccu_tel device for bed 6.There are multiple tachycardia and extreme tachycardia alarms on the log prior to this event which have been acknowledged (silenced) at the central station.There is a ventricular fibrillation/tachycardia (vent fib/tach) generated at 05:36.This alarm was not acknowledged at the central station.Per the customer's alarm configuration, if the red alarm is not acknowledged, the red alarm remains latched, which means the alarm sound and banner will continue and no other alarms will be displayed or announced until the red alarm is acknowledged.Based on the analysis, the mx40 was working as intended.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and retrieved logs.A philips product specialist engineer (pse) and a clinical application specialist (cas) reviewed the audit logs, which indicated multiple tachycardia and extreme tachycardia alarms were generated at the central station and were acknowledged by the user.There was also a red vent fib/tach alarm which occurred but was not acknowledged.Per the customer's alarm configuration, if the red alarm is not acknowledged, the red alarm remains latched, which means the alarm sound and banner will continue and no other alarms will be displayed or announced until the red alarm is acknowledged.After the vent fib/tach alarm occurred, there were multiple "ecg lead off" alarms generated, followed by the equipment going offline.Per the analysis, the device was working as intended.Based on this information, the device did not cause or contribute to the reported event; however, clinical workflow or alarm management appears to be a factor.

• Brand Name: INTELLIVUE MX40 2.4GHZ
• Type of Device: INTELLIVUE MX40 2.4GHZ
• 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: 18781761
• MDR Text Key: 336281926
• Report Number: 1218950-2024-00134
• 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,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• 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