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

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.

• 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 Key: 6614220
• MDR Text Key: 76747539
• Report Number: 6614220
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 FDA: 03/14/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1