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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 Delayed Alarm (1011)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/29/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and reviewed the logs and determined the spo2 alarms are performing as expected.The customer was provided information on how to configure the sp02 setting delay times.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
 
Event or Problem Description
Philips received a complaint on the intellivue mx750 patient monitor indicating that the nurses are observing alarm delays on the spo2 alarms.The device was in use on a patient at time of event, there was no adverse event 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 Key25580406
Report Number9610816-2026-101200
Device Sequence Number9277305
Product Code MHX
UDI-Device Identifier00884838083332
UDI-Public(01)00884838083332
Combination Product (Y/N)N
Initial Reporter StateFL
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) 06/22/2026
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 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 05/29/2026
Initial Report FDA Received Date06/22/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured09/16/2025
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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