MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G

Model Number 865352

Device Problem Wireless Communication Problem (3283)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2023

Event Type  Death  

Manufacturer Narrative

The available information and logs were reviewed by product support engineer (pse).Preliminary review of clinical audit logs revealed telemetry went offline at 23:36 after alerting for a 'weak signal" inop and then came back online at 23:43, generating a 'ecg leads off' inop at 23:44; therefore, no further data was stored at the pic ix after that time and the patient's death was pronounced at 00:09.The investigation found no malfunction of the patient information center ix (pic ix) system during the time in question.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.Pic mfr report number: 1218950-2023-00928.Reporting institution phone number: (b)(6) reporter phone number: (b)(6).

Event Description

It was reported the patient was on telemetry in the progressive critical care unit (pccu).It was reported the patient ambulated into the bathroom; the telemetry unit (mx40) stopped working at 12:36.Patient death was confirmed at 00.09.The customer reported on this occasion this death was not preventable even if device was fully working.

Manufacturer Narrative

A remote service engineer (rse) confirmed from the customer that on (b)(6) 2023 a patient was on telemetry 11 on pccu bedspace 2.1, there was a lost connection to mx40 wi-fi version from the pic ix.The time of death was at 00:09 on (b)(6) 2023.The customer informed that on this occasion the death was not preventable even if the device was fully working.A philips technical consultant (tc) reviewed the logs and determined that the telemetry went offline at 23:36 after alerting for a 'weak signal" inop and then came back online at 23:43.An (electrocardiogram) ecg leads off inop was generated at 23:44.The root cause for this issue was due to a customer network wi-fi infrastructure issue.This caused the mx40 to disconnect so no data was going to the picix, however, it provided the offline inop per specifications.The patient's death was pronounced at 00:09.Based on the information available and the testing conducted, the cause of the reported problem was due to the customer's wi-fi infrastructure.The philips device was found working according to specification and no fault was found.

Event Description

Customer reported the patient ambulated into the bathroom; the telemetry unit stopped transmitting at 12:36.The patient death was confirmed at 00:09.The exact cause of death is unknown, however, it was reported that the death was not preventable even if the device was transmitting data correctly.The device was in clinical use.The patient passed away.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: INTELLIVUE MX40 802.11A/B/G
• 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: 18357704
• MDR Text Key: 330898498
• Report Number: 1218950-2023-00941
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• 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,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2014
• 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