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

Model Number 867030

Device Problem Defective Alarm (1014)

Patient Problems Ventricular Fibrillation (2130); Asystole (4442)

Event Date 03/09/2024

Event Type  Death  

Event Description

It was reported while monitoring in the emergency department, the patient went into asystole but no alarms were generated at the pic ix.The patient subsequently passed away.The device was in use on a patient.There was a report of patient or user harm.

Manufacturer Narrative

E1: reporter phone # (b)(6).A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Related to mfr report number 1218950-2024-00210.A field service engineer (fse) went onsite to collect the logs and evaluated the monitor.The logs revealed that alarms and inops were generated and acknowledged at the bedside and at the pic ix for the time in question.Based on the information provided the x3 performed as specified when tested to generate alarms.Alarms are logged in the clinical audit log which were acknowledged at the bedside and at the pic ix.The evaluation revealed that the device was working as intended.

Event Description

It was reported while monitoring in the emergency department, the patient went into asystole but no alarms were generated at the pic ix.The patient subsequently passed away with the official cause of death determined to be ventricular fibrillation.The device was in use on a patient.There was a report of patient or user harm.

• 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: 18933162
• MDR Text Key: 338025758
• Report Number: 9610816-2024-00158
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/12/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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