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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 No Device Output (1435)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/09/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis was performed by the rse and customer.The customer reports bedside monitors spontaneously lost custom profile for this unit.The rse advise the customer to check if anybody in the biomed department has a copy of the intelliview support tool.The customer will email back.Based on this information, there does not appear there was a device malfunction that contributed to the reported event.The customer emailed back and was able to reconfigure the monitor with the support tool.No other information was made available.
 
Event or Problem Description
Philips received a complaint on an intellivue mx750 patient monitor indicating that the bedside monitors spontaneously lost custom profile for this unit.The device was in clinical use at time of event, no adverse event was reported.
 
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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
70314632031
MDR Report Key25733807
Report Number9610816-2026-101345
Device Sequence Number10453976
Product Code MHX
UDI-Device Identifier00884838083332
UDI-Public(01)00884838083332
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
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 Health Professional,User Facility
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 07/07/2026
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 Health Professional
Device Model NumberINTELLIVUE PATIENT MONITOR MX750
Device Catalogue Number866471
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 06/09/2026
Initial Report FDA Received Date07/07/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured09/12/2024
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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