MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number	INTELLIVUE PATIENT MONITOR MX700
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an alarm problem.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional 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.The manufacturing date for the reported device is prior to 24 sept 2016 so no udi required.Reporting institution phone # (b)(6).
Additional Manufacturer Narrative
A philips remote service engineer (rse) reviewed the device logs.Indicating there was no asystole alarm in the period mentioned, but saw that for more than one hour the patient was in tachycardia.The rse state that the patient's traces could not be recovered because the department does not admit patients at the central station which is why the traces were not available.The rse concluded that ecg derivation iii may have been flat due to a false contact but that the ecg derivations on which the ecg analysis is done displayed an analyzable signal the monitor did not detect any condition of asystole, not tachycardia, as there was a measurable ecg signal and asystole would mean that the ecg is flatlining.The customer was advised to display derivation ii instead of derivation iii because it is the main derivation for the analysis.The rse confirmed the configuration was modified on the monitors.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The reported problem was confirmed.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The reported problem was not confirmed.
Event or Problem Description
Philips received a complaint on the intellivue mx700 patient monitor indicating there was no asystole alarm for the patient.The device was in use monitoring a patient at the time of the event.An adverse event involving a patient or user was reported.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX700 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 ; 70314632031
• MDR Report Key: 21894423
• Report Number: 9610816-2025-000339
• Device Sequence Number: 3530370
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: INTELLIVUE PATIENT MONITOR MX700
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown