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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Philips Medical Systems Patient Information Center iX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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Philips Medical Systems Patient Information Center iX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Back to Search Results
Model Number Patient Information Center iX
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/13/2026
Type of Reportable Event Malfunction
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Brand Name
Patient Information Center iX
Common Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Manufacturer (Section D)
Philips Medical Systems
3000 minuteman rd
andover MA 01810
Manufacturer (Section G)
Philips Medical Systems
3000 minuteman rd
andover MA 01810
Manufacturer Contact
deborah currlin
3000 minuteman rd
andover, MA 01810
+1(617)245-5900
MDR Report Key50159640
Report Number1218950-2026-100539
Device Sequence Number15726428
Product Code MHX
UDI-Device Identifier00884838048645
UDI-Public(01)00884838048645(10)B.02.18
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K153702
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) 08/06/2026
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 NumberPatient Information Center iX
Device Catalogue Number866389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2026
Initial Report FDA Received Date08/06/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/24/2020
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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