MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE MX40 WLAN

Model Number 865352

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2023

Event Type  Death  

Event Description

The customer requested the device log for an event on (b)(6) 2023 between 07:00 and 07:30 for the patient in room 603.The device was in use monitoring a patient at the time of the reported event.The death of the patient was reported.

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

It was stated the patient died, however the mx40 did not contribute to the adverse event.Based on review of the available data, the monitoring equipment was functioning as specified.Audit logs were reviewed by the product support engineer (pse) and the following information was provided.The reported incident timeframe was 07: to 07:30 on 02-apr-2023.Monitoring continued well beyond 07:30.It was noted that the audit logs that were provided for review were filtered log files.A review of the pic ix audit log provided shows multiple **yellow respiration rate and heart rate limit violation alarms, as well as ***red xtachy alarms during the reported incident timeframe.There are no equipment offline / equipment online activities logged.Connection/communication between the mx40 and pic ix was stable throughout the incident timeframe.The device was confirmed to be operating per specifications and no failure was identified.The device remains at customer site.

• Brand Name: INTELLIVUE MX40 WLAN
• Type of Device: INTELLIVUE MX40 WLAN
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 16901336
• MDR Text Key: 314888420
• Report Number: 1218950-2023-00312
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• 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
• Report Date: 05/10/2023

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: 04/21/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/17/2023
• Date Device Manufactured: 01/13/2014
• 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