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

Model Number 865351

Device Problems Defective Alarm (1014); No Audible Alarm (1019)

Patient Problem Cardiac Arrest (1762)

Event Date 08/27/2023

Event Type  Injury  

Event Description

The customer reported that the system did not alarm.The patient experienced cardiac arrest.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

The limited information provided was reviewed by a philips clinical specialist and a philips medical safety manager noted below: the strips provided show some beats labeled ¿a.¿ if the signal quality is not good, the algorithm will assign the beat label ¿a¿ for artifact.Good skin preparation is crucial to successful monitoring.A clean signal is integral to accurate arrhythmia monitoring.A noisy signal makes it difficult to detect and classify beats accurately, thus affecting event detection and alarm generation.(star app note page 2).The following are some possible causes of noisy ecg signals: poor skin preparation; dried electrode gel; detached electrodes; broken lead wires; muscle artifact caused by shivering, movement, or tremors; baseline wander caused by excessive chest movement or the offset differences between two brands of electrodes; respiration artifact caused by thoracic or abdominal movement of both spontaneous and ventilated breathing patterns; and interference from equipment.If 20 of the last 30 seconds are classified as either noisy or questionable (displayed by delayed beat annotations as predominantly ¿a¿ or ¿?¿), a cannot analyze ecg inop/technical alarm is generated.When the algorithm cannot reliably analyze the ecg data, per the ifu, the system is designed to provide/display a "cannot analyze ecg inop".The intellivue mx400-800 ifu says to check the ecg signal quality of the selected primary and secondary leads.If necessary, improve lead position or reduce patient motion.Based on the review of the audit log, the system did not generate an asystole alarm.The information provided states the patient was having muscular convulsions with the arrest.This is most likely resulted in the star algorithm classifying some beats as artifact (identified as beats labeled ¿a¿).Based on the available information, we cannot confirm the system displayed the ¿cannot analyze ecg inop¿, but when the algorithm cannot reliably analyze the ecg data, per the ifu, a "cannot analyze ecg inop¿ is displayed.The information provided states the patient was having muscular convulsions with the arrest.This is most likely resulted in the star algorithm classifying some beats as artifact (identified as beats labeled ¿a¿).

• 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: 17809383
• MDR Text Key: 324160491
• Report Number: 1218950-2023-00688
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• 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 Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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): Life Threatening