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U.S. Department of Health and Human Services

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

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700 Back to Search Results
Model Number INTELLIVUE PATIENT MONITOR MX700
Medical Device Problem Code Device Fell (4014)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/19/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included checking , testing and examination of all alleged malfunctional devices.The x2 was mounted to an intellivue mounting solutions which is used with the intellivue mx700.The results of the analysis were that the assy plate of the mount was defective and needed replacement.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a defective assy plate mount.The issue was resolved by replacing the defective parts and the device is back in service.The x2 will be investigated in a separate complaint.E1: reporting institution phone#: (b)(6).
 
Event or Problem Description
It was reported that a x2 measurement server fell of the mount.The device was in clinical use.There was no report of patient or user harm.
 
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Brand Name
INTELLIVUE PATIENT MONITOR MX700
Common Device Name
INTELLIVUE PATIENT MONITOR MX700
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 Key24615997
Report Number9610816-2026-100521
Device Sequence Number10138012
Product Code MHX
UDI-Device Identifier00884838029088
UDI-Public(01)00884838029088
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K150310
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) 03/17/2026
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 MX700
Device Catalogue Number865241
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 02/19/2026
Initial Report FDA Received Date03/17/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/20/2020
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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