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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR
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PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR Back to Search Results
Model Number 866389
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that a replacement loudspeaker was needed.The device was not in use on a patient.
 
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Brand Name
INTELLIVUE INFORMATION CENTER IX
Type of Device
CENTRAL STATION MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11021312
MDR Text Key222292824
Report Number1218950-2020-07863
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838093041
UDI-Public(01)00884838093041
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K102495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/09/2020
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
Device Operator Health Professional
Device Model Number866389
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received12/09/2020
Supplement Dates FDA Received01/14/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2020
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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