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U.S. Department of Health and Human Services

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

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PHILIPS ULTRASOUND, INC. SPARQ; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2017
Event Type  malfunction  
Event Description
Unit failed to boot up for a fast scan during a trauma case.Philips (the oem) inspected the unit and found the unit was functioning up to manufacturer's specifications.Error logs were reviewed, and found that the unit was most likely used until the battery was completely drained, resulting in an abnormal shutdown.The delay in the device booting up was most likely caused by the system recovering from the abnormal shutdown.The device was released back into service after the oem confirmed that there was nothing wrong with the device.
 
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Brand Name
SPARQ
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy
bothell WA 98021
MDR Report Key6614220
MDR Text Key76747539
Report Number6614220
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2017,05/17/2017
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/14/2017
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer03/14/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2017
Type of Device Usage N
Patient Sequence Number1
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