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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC SPARQ ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

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PHILIPS ULTRASOUND, INC SPARQ ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Lot Number US4191
Device Problems Inadequate User Interface (2958); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 06/11/2021
Event Type  malfunction  
Event Description
Philips sparq ultrasound machine not working.Buttons remain frozen with message that states "the system experienced an error and is collecting data.Please record the following information and contact your philips service representative.Diagnostic code (b)(6)." equipment tagged and sent to biomed for service.
 
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Brand Name
SPARQ ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett hwy
bothell WA 98021
MDR Report Key12287149
MDR Text Key265367271
Report Number12287149
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/03/2021,06/29/2021
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 No Information
Device Lot NumberUS4191
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/03/2021
Date Report to Manufacturer08/06/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/06/2021
Type of Device Usage Unknown
Patient Sequence Number1
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