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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS COMPONENT MONITORING SYSTEM
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PHILIPS MEDICAL SYSTEMS COMPONENT MONITORING SYSTEM Back to Search Results
Model Number M1165A
Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that the cms monitor did not announce acoustically the inop "ecg electrodes off" alarm.The nurse came into the room and saw the ecg flatline and visually the ecg electrodes off alarm, but there was no audio alarm.The nurse tested the alarm behavior and the monitor announced visually and acoustically the ecg electrodes off alarm.There was no pt incident or delay in treatment.
 
Manufacturer Narrative
(b)(4).A follow up report will be submitted upon completion of the investigation.
 
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Brand Name
COMPONENT MONITORING SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str. 2
boeblingen 71034
GM  71034
Manufacturer Contact
denyse murphy
3000 minuteman road
andover, MA 01810
9786597844
MDR Report Key3824343
MDR Text Key4453813
Report Number9610816-2014-00117
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K002758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2014
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 NumberM1165A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/14/2014
Initial Date FDA Received05/05/2014
Was Device Evaluated by Manufacturer? No
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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