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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. IE33 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND, INC. IE33 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 8500-0082-01
Device Problems Loss of Power (1475); Device Stops Intermittently (1599)
Patient Problem No Information (3190)
Event Date 09/26/2017
Event Type  malfunction  
Event Description
Ultrasound monitor intermittently blacks out; monitor is turned back on and it will shut off. Repeat issue. Monitor replaced 3 months ago and video cards replaced 5 months ago.
 
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Brand NameIE33 DIAGNOSTIC ULTRASOUND SYSTEM
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC.
3000 minuteman road
andover MA 01810
MDR Report Key6934391
MDR Text Key88865691
Report Number6934391
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8500-0082-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/28/2017
Event Location Hospital
Date Report to Manufacturer09/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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