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

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

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.

Event Description

The customer reported that there were no alarms for v-tach.The device was in use on patient at time of event, there was no adverse event reported.

Manufacturer Narrative

A philips product support engineer and philips clinical specialist reviewed the logs, strips and information provided.One of the strips provided indicated the rhythm has beat labels of n which means the algorithm would not issue a vtach alarm.Ppd data received was only from one of the beds (the patient had been transferred).The.Ppd data was for only 40 seconds and show a learning phase was occurring while the patient was in a ventricular rhythm.This is most likely the reason the beats are labeled as n instead of v.The star application note and the product instructions for use (ifu) guides indicate how many runs are required to identify and alarm for v-tach.The definition for vtach is a run of consecutive beats labeled as v with run length greater than or equal to the v-tach run limit and ventricular hr greater than tthe v-tach hr limit.The factory setting for the v-tach run is 5 and the v-tach hr is 100.The star algorithm had classified the beat as n instead of v.Because of this, the criteria for vtach was not met, hence there was no alarm for vtach generated.Once the algorithm detects and measures the qrs, the beat is labeled as n (normal), s (supraventricular), v (ventricular ectopic), or p (paced).To aid the algorithm in labeling a new beat, previously detected beats that have similar shapes are grouped into template families.Each patient can have up to 16 different active template families for each individual lead.To keep the template family information current, they are dynamically created and replaced as the patient¿s beat morphology change.If a patient begins to display a new beat morphology, a new template family is created.Older template families from beats no longer experiencing are automatically deleted.The following warning is found in the ifu: warning if arrhythmia learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal qrs complex.This may result in missed detection of subsequent events of v-tach and v-fib.For this reason you should: ¿ take care to initiate arrhythmia relearning only during periods of predominantly normal rhythm and when the ecg signal is relatively noise-free ¿ be aware that arrhythmia relearning can happen automatically ¿ respond to any inop messages (for example, if you are prompted to reconnect electrodes) as the effectiveness of the arrhythmia monitoring for the patient is compromised ¿ be aware that a disconnected easi electrode triggers an arrhythmia relearn on all leads ¿ always ensure that the arrhythmia algorithm is labeling beats correctly.The reported problem was not confirmed.Following the profile load, when the patient was transferred to this device and connected to the monitor, there continues to be multiple high hr, pair pvc, low nbp, and low spo2 alarms.Again, the star algorithm had classified the beat as n instead of v.Because of this, the criteria for vtach were not met, hence there was no alarm for vtach generated.The star algorithm is designed for continuous monitoring and is a tool to assist the clinician in managing and evaluating their patients.It is not designed to be a replacement for human surveillance and sound clinical judgement.Information was provided to the customer to resolve the issue and the device remains in use.Related cases are reported under mfr report numbers 1218950-2024-00243, 1218950-2024-00233 and 9610816-2024-00179.

• 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: 19032370
• MDR Text Key: 339242875
• Report Number: 1218950-2024-00232
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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 Sex: Female