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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 04/28/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer, who reported that all sectors were blank and stations were operating in local mode with no central monitoring.The rse inquired about any recent power outages, network maintenance, or migrations; the customer reported none.The rse logged into the primary server and observed that the webserver, physio servers, and mobility server were online, while the majority of other servers/hosts showed status as "unknown" (no connectivity/heartbeat).Onsite support was paged for immediate physical and network troubleshooting and escalation.The customer later stated that the issue was resolved and onsite support was no longer needed.No additional information was provided.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 the entire hospital lost central monitoring; units are in local mode and sectors show blank with no patient data.The device was in use on patient at time of 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 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 Key25148990
Report Number1218950-2026-100310
Device Sequence Number10745151
Product Code MHX
UDI-Device Identifier00884838086715
UDI-Public(01)00884838086715(10)C.02.02
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K163584
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) 05/12/2026
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 04/29/2026
Initial Report FDA Received Date05/12/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured01/28/2019
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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