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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 INFO CNTR LOCAL DATABASE REL N.0; CENTRAL STATION MONITOR
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PHILIPS MEDICAL SYSTEMS M3150 INFO CNTR LOCAL DATABASE REL N.0; CENTRAL STATION MONITOR Back to Search Results
Model Number M3150
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the central station froze for the second time, the mouse pointer disappeared and all the patient waveform traces disappeared.After a reboot everything worked normally again.The patient was being monitored at the central station at the time that the incident was discovered.There was no report of patient injury or harm.
 
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Brand Name
M3150 INFO CNTR LOCAL DATABASE REL N.0
Type of Device
CENTRAL STATION MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
denyse murphy
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6706192
MDR Text Key79942674
Report Number1218950-2017-04639
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K081983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2012
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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