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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 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 Disconnection (1171)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/01/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
Event or Problem Description
Philips received a complaint on a patient information center ix (pic ix) indicating that all hosts lost connectivity with the primary server on (b)(6) 2026, between 1:00 am and 3:00 am.The primary server was connected; the biomed restarted the pic ix services on the primary to resume connectivity with the other hosts.The system is up and operational.The biomed is requesting root cause analysis.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
 
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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 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 Key25278215
Report Number9610816-2026-101027
Device Sequence Number13285479
Product Code MHX
UDI-Device Identifier00884838122772
UDI-Public(01)00884838122772(10)4.3.2.0
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K211900
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,Followup
Report Date (Section B) 07/20/2026
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 05/01/2026
Supplement Date Received by Manufacturer06/26/2026
Initial Report FDA Received Date05/26/2026
Supplement Report FDA Received Date07/20/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured10/17/2024
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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