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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 Problems Nonstandard Device (1420); Loss of Power (1475); Computer Operating System Problem (2898)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer experienced an untimely network outage that caused the surveillances to reboot resulting in the 2018 adt reboot issue.There was no patient incident.
 
Manufacturer Narrative
 
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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
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7263961
MDR Text Key99919397
Report Number1218950-2018-01645
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K102495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/16/2018
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? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/16/2018
Initial Date FDA Received02/12/2018
Supplement Dates Manufacturer Received01/16/2018
Supplement Dates FDA Received04/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2017
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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