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

Model Number 865351

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2023

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 institution phone#: (b)(6).

Event Description

It was reported a patient being monitored by a telemetry device passed away.The customer indicated the central station was alarming; however, the secondary alarm forwarding to the nurse call was not alarming.The customer requested onsite assistance gathering the device logs.Device logs were retrieved and provided to the product support engineer for evaluation.The patient information center ix in use during this event is reported in mfr number 1218950-2023-00863.

Manufacturer Narrative

The product support engineer (pse) identified that there is radio frequency data acquisition (rfda) and devicedebug log data for bed label tele-8 in the reported incident timeframe.There is audit log data for the incident timeframe and device in question.The mx40 pwm logs were not collected.The rfda log shows that there are signal issues during the reported timeframe (mx40 to pic ix), but the mx40 remained connected to the pic ix.The rfda log shows the connection between device tele-8 (bed label htg1-8) and the patient information center ix (pic ix) being aborted at 06:27:24 on (b)(6) 2023, at which time the patient was discharged from the pic ix.The device debug log shows a battery change for device/bed label tele-8/htg1-8 at 09:58:05 on (b)(6), 2023.No other activity was captured during the incident timeframe.The audit log shows ongoing activity for device label/bed label tele-8/htg1-8 throughout the timeframe of 01:30 through 06:27 on october 20, 2023.Physiological alarms were being provided for asystole, vent fib/tachy, hr low limit violations, afib, pause, and irregular hr event as the patient¿s condition changed.Technical inop alarms were provided for tele weak signal, cannot analyze ecg, and ecg leads off (r lead (right arm) events.The audit log shows the patient was discharged at 06:27:24 on (b)(6), 2023.The audit log shows the patient was readmitted at 08:12:34 on (b)(6), 2023.No further activity for device/bed tele-8/htg1-8 is captured.The readmit may have been to review data.The audit log data ends at 08:12:34 on (b)(6), 2023.The logs indicate that the philips equipment is performing as specified.It is further determined that the philips device did not cause or contribute to the patient death.The customer is using tunstall nurse call system.This secondary alarming system is alleged to not have alarmed.Additional information regarding the tunstall system has been requested.A follow-up report will be submitted once the investigation is completed.

Manufacturer Narrative

The logs indicate that the philips equipment is performing as specified.It is further determined that the philips device did not cause or contribute to the patient death.The customer is using tunstall nurse call system (a non-philips product).This secondary alarming system is alleged to not have alarmed.Additional information regarding the tunstall system was requested, however no additional information was received.The philips product support engineering (pse) log review indicates and the customer was certain the alarms were being generated at the patient information center ix (pic ix).This confirms alarming at the mx40 device as the pic ix receives the information from the mx40.The secondary alarms were not being sent to the non-philips nurse call system.Per the pse, the ifu states 'the paging system is a secondary alarm notification system and is not intended for primary notification of alarms, physiological data, or demographic data.Receipt by the external software device of alerts is not confirmed, and delivery to the paging device is not guaranteed.' the clinical audit log review revealed the philips devices were performing as specified and manufacturer-specific performance is to be addressed by the customer with that manufacturer.

• 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: 18160230
• MDR Text Key: 328407397
• Report Number: 1218950-2023-00865
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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