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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor MX750; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor MX750; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Back to Search Results
Model Number IntelliVue Patient Monitor MX750
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/11/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during testing the diastolic pressure seems to be underestimated.The device was not in use on a patient at the time of the event.There was no adverse event reported.
 
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.Reporting institution phone # (b)(6).Reporter phone # (b)(6).
 
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Brand Name
IntelliVue Patient Monitor MX750
Common Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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
+49(703)14632031
MDR Report Key50852582
Report Number9610816-2026-101974
Device Sequence Number18554663
Product Code MHX
UDI-Device Identifier00884838083332
UDI-Public(01)00884838083332
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K210906
Number of Events Summarized1
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 Nurse
Type of Report Initial
Report Date (Section B) 09/22/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberIntelliVue Patient Monitor MX750
Device Catalogue Number866471
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/11/2026
Initial Report FDA Received Date09/22/2026
Date Device Manufactured05/20/2026
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 Number1
Patient SexUnknown
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