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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3151 INFORMATION CENTER CLIENT REL N.0; CENTRAL STATION MONITOR
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PHILIPS MEDICAL SYSTEMS M3151 INFORMATION CENTER CLIENT REL N.0; CENTRAL STATION MONITOR Back to Search Results
Model Number M3151
Device Problems Device Inoperable (1663); Operating System Becomes Nonfunctional (2996)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the piic monitor froze up.The ¿system¿ gives the appearance that it is working, however, the waves and parameter values are not updating.In some cases the clock (time) does not update and the mouse and keyboard do not respond.There was no patient injury or harm reported.
 
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Brand Name
M3151 INFORMATION CENTER CLIENT REL N.0
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 Key7427157
MDR Text Key105414714
Report Number1218950-2018-03363
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3151
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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