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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX
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PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX Back to Search Results
Model Number 866389
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2022
Event Type  malfunction  
Event Description
The customer reported an intellivue telemetry system failure, a sitewide no data telemetry error message, and an inconsistency with viewing patient data.The device was not in use on a patient at the time of the event.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported an intellivue telemetry system failure, a sitewide no data telemetry error message, and an inconsistency with viewing patient data.The device was not in use on a patient.
 
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Brand Name
PATIENT INFORMATION CENTER IX
Type of Device
PATIENT INFORMATION CENTER IX
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key13841289
MDR Text Key287597508
Report Number1218950-2022-00233
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838093041
UDI-Public00884838093041
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866389
Device Catalogue Number866389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/23/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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