MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Device Alarm System (1012)

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

Event Date 04/26/2023

Event Type  Death  

Event Description

It was reported that the customer expected product to alarm in case of emergency.Perceived result is that no alarms were noticed at the moment of the incident.The patient expired.A philips technical consultant (tc) was call on site to do a test and verification test for the device being "used" at the moment.

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

G3 date received by manufacturer was corrected.The date in the initial report was incorrect.Diagnostic/functional testing was performed and the mx40 was functional.The mx40 logs provided do not capture alarm events.The mx40 pwm log shows a battery change at 12:55 pm on (b)(6) 2023.It appears the device reconnected to the pic ix after the battery change based on the subsequent standby invocation, which was performed at the pic ix.Based on the available information, it is likely the mx40 was powered on and connected to the pic ix during the timeframe around 01:03 am on (b)(6) 2023.The device was put into standby mode at 02:25 am on (b)(6) 2023.Standby was invoked at the pic ix (central).Attempts were made to clarify the details if the incident including a clear description of the incident, date and time of the event, expected alarms and cause of death, but the customer response was asked but unknown (asku).The customer did state that the mx40 telemetry was functional after testing.Clarification around this statement was also requested to determine if the devices did not contribute to the patient death,but there was no response from the customer.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The pic ix device in use at the time of the event is reported in mfr report number 1218950-2023-00360.The intellivue mx400 patient monitor device used during this event is reported in mfr report number 9610816-2023-00517.

Event Description

The customer reported on (b)(6) 2023, at approximately 01:03 the monitor failed to alarm for cardiac arrest.The patient was not revived and expired.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• 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: 17471764
• MDR Text Key: 320518856
• Report Number: 1218950-2023-00534
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2019
• 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