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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DETECTOR AND ALARM, ARRHYTHMIA

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PHILIPS MEDICAL SYSTEMS DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number MX40 1.4
Device Problem No Audible Alarm (1019)
Patient Problems Ventricle, Abnormality Of (2078); Loss of consciousness (2418)
Event Date 08/17/2017
Event Type  Malfunction  
Event Description

Patient felt he passed out. Patient showing ventricular standstill on the monitor but the telemetry monitor did not ring for a red alarm.

 
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Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key6886426
MDR Text Key87019916
Report Number6886426
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMX40 1.4
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2017
Event Location Hospital
Date Report TO Manufacturer08/22/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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