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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 4.4
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/28/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis was performed by a philips remote service engineer (rse).The rse accessed philips remote services (prs) to reach the primary server.The network and overall health seemed to be functional.It was determined that there was a multicast failure with care integration (ci) master, so the ci master was located and rebooted to fix the issue.Based on the results of the analysis, the cause of the reported problem is unknown.As the reboot resolved the issue, the cause was unable to be traced to one thing and is unknown.The device was operational after performing the reboot.
 
Event or Problem Description
Philips received a complaint on the patient information center ix indicating that system pic stations lost patients vital coming across.The device was in use on a patient at the time of the event.There was no adverse event 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 Key25906348
Report Number9610816-2026-101488
Device Sequence Number14937560
Product Code MHX
UDI-Device Identifier00884838127067
UDI-Public(01)00884838127067(10)4.4.5.0
Combination Product (Y/N)N
Initial Reporter StateAK
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
Report Date (Section B) 07/22/2026
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 Number4.4
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 06/28/2026
Initial Report FDA Received Date07/22/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured08/25/2025
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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