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

Model Number 867030

Device Problem Device Alarm System (1012)

Patient Problem Tachycardia (2095)

Event Date 01/07/2024

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.E1: (b)(6).

Event Description

The customer reported that a patient sustained a ventricular tachycardia without the scope does not sound a vital alarm.Only a yellow alarm sounds for a known tachycardia.The team tried to resuscitate her for thirty minutes without success.

Manufacturer Narrative

The customer reported that at around 10:30 on (b)(6) 2024, on the room 404, the patient presented with sustained ventricular tachycardia, but the scope did not sound a vital alarm.Only a yellow alarm sounded for a known tachycardia.10:40: the patient presents with ventricular fibrillation with an alarm on the monitor.The patient is in rca (cardiac respiratory arrest).The team tries to resuscitate her for thirty minutes without success.Failure to monitor and delay in management (ventricular tachycardia not managed for approximately 7 minutes) patient death.A philips application engineer visited onsite, and it was found that all arrhythmias are deactivated by default within the customer¿s current alarm configuration.The customer was unaware of this.Therefore, based on available information, the device worked as designed and configured.The device may have contributed to the reported patient event by way of user¿s selected alarm configuration/management and/or clinical workflow.A philips engineer visited customer site to change the arrhythmia and blood pressure alarms which are aberrant.A good faith effort (gfe) conducted to obtain the logs and rse informed that the data for the incident of (b)(6) 2024 at around 10:30 am is no longer available, philips was only informed on (b)(6) 2024.Tracings and patient information can be reprinted for a maximum of 7 days.Based on the information available, the cause of the reported problem seems to be an issue with alarm configuration/management.The reported problem was not confirmed.The engineer provided their analysis findings.The device worked as designed and configured.The cause was related to customer usage/awareness of the device functionality.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18686648
• MDR Text Key: 335140905
• Report Number: 9610816-2024-00068
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/02/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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