MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

Model Number 867030

Device Problems Incorrect Measurement (1383); Protective Measures Problem (3015)

Patient Problems Arrhythmia (1721); Insufficient Information (4580)

Event Date 11/10/2022

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the patient has a pacemaker and was admitted with pacemaker setting ¿unconfirmed¿.The surveillance showed alarms for ventricular arrhythmia and 10 minutes later the patients relative informs the nursing staff that the patient most likely had passed away.The nursing staff confirmed that the patient had passed away.Despite that, the x3 is showing a heart rate of 60 bpm.

Event Description

The customer reported that around 20.18 o´clock the surveillance ((b)(6)) alarmed for ventricular arrhythmia and ten minutes later, the patients relative informed the staff that the patient most likely has passed away.The patient had a pacemaker and was admitted with pacemaker setting ¿unconfirmed¿ which was probably at a default setting of 60 beats/min.The staff confirmed the patient passed away probably between 20.18 and 20.27, despite the x3 readings that indicated a heart rate of 60 bpm.Even after the patient dies, the pacemaker continues to go and generate a complex that the monitor algorithm correctly interprets as a pacemaker rhythm.The alarm criteria for an asystole alarm is an r-r interval of more than 4.0 seconds.This alarm criteria was never under the case.The qrs amplitudes in the ventricular beats which result (generate chamber rhythm alarms when the frequency is below the limit for vt) exceed 0.5 mv, which is a recommended lowest level for good qrs detection.Before and during the time for the last chamber rhythm alarm they had an alarm for respiration - loose ekg electrodes which made them not have had any respiration monitoring active at the time.They have also had an alarm for no/poor spo2 signal and/or no spo2 transmitter connected which made no alarm when the patient's pulse disappeared or when the patient potentially has desaturated.The system responded as expected per the configuration.A review of the log files by the clinical application specialist (cas) concluded that the pic ix system and x3 monitor behaved as intended.No further investigation or action is warranted at this time.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes, the device was in use monitoring a patient at the time of the reported event.Was there any adverse event to the patient or user? if yes, describe? yes the patient passed away from possible cardiac arrest.If there was an adverse event, did the device cause or contribute to the adverse event, and how? there was no allegation the device caused or contributed to the patient's death.

• Brand Name: INTELLIVUE X3
• Type of Device: INTELLIVUE X3
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15811046
• MDR Text Key: 303790355
• Report Number: 9610816-2022-00583
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K171801
• 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

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: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2020
• 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
• Patient Age: 91 YR
• Patient Sex: Male