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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 Defective Alarm (1014)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/27/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).A philips field service engineer (fse) evaluated the device, and the issue was due to customer network that was solved by hospital it.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 patient information center ix indicating that alarms from different monitors do not appear.The device was in use at the time of the event.No adverse event occurred.
 
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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
6172455900
MDR Report Key24283898
Report Number1218950-2026-100039
Device Sequence Number8319067
Product Code MHX
UDI-Device Identifier00884838048645
UDI-Public(01)00884838048645(10)C.03.10
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K183387
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 Biomedical Engineer
Type of Report Initial
Report Date (Section B) 02/06/2026
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? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/27/2026
Initial Report FDA Received Date02/06/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured04/17/2024
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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