MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR

Model Number 866060

Device Problem Defective Alarm (1014)

Patient Problem Bradycardia (1751)

Event Date 11/20/2023

Event Type  Death  

Event Description

It was reported the mx400 patient monitor did not alarm for bradycardia.The device was in use on a patient.There was a report of death of a patient.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.E1: reporting institution phone: (b)(6).E1: reporter phone (b)(6).

Manufacturer Narrative

Philips received a complaint on the intellivue mx400 patient monitor indicating that the monitor did not alarm for bradycardia for a stimulated patient on (b)(6) 2023, at 6:30 p.M.The device was in use on a patient, and there was a report of death of the patient.A good faith effort (gfe) was performed to clarify additional details regarding the patient incident, but no further clarifying information was provided.The remote service engineer (rse) spoke with the customer and found that the ¿stimulated patient¿ checkmark was selected upon admission to the monitor or to the central unit.To the tester, the bradycardia tolerance was 90, and the pacemaker was 75, but the device did not alarm at all.The nurses said that alarms never sound in bradycardia and only 15 minutes after cardiac arrest the asystole alarm sounds.The complaint was escalated for technical investigation and the results indicate that there is insufficient information available, and the provided logs cannot be reviewed as the bed information is contradictory between the logs that were received and what was stated in the complaint.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.It is unknown how this issue was resolved.The customer did not provide any additional details; therefore, the cause cannot be determined at this time.It was indicated that the customer requested assistance in configuring the alarms of the central station, particularly in stimulated mode, but the customer advised that they would open a new case.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device / logs not made available by customer.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• Type of Device: INTELLIVUE MX400 PATIENT MONITOR
• 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: 18407914
• MDR Text Key: 331471382
• Report Number: 9610816-2023-00689
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• UDI-Public: 00884838038752
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130849
• 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: 866060
• Device Catalogue Number: 866060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2016
• 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): Death