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 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the monitor did not alarm for bradycardia.A patient death was reported.It is unknow if the device was in use at time of the event.There was a report of patient or user harm.

Event Description

It was reported that the monitor did not alarm for bradycardia.A patient death was reported.It is unknown if the device was in use at time of the event.There was a report of patient or user harm.

Manufacturer Narrative

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.A good faith effort (gfe) was performed to obtain further information, but none was provided.Based on the available information, the exact cause for the reported issue could not be established.

• 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: 18356859
• MDR Text Key: 331195332
• Report Number: 9610816-2023-00680
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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