MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC SPARQ ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 795090

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Customer reported a 1 hour delay in rebooting the sparq ultrasound system during a procedure.Due to the extended time the patient was sedated the decision was made to report this event.Evaluation results of the system are expected to be provided in a follow up report.

Event Description

Customer words: not sensing start button, have to press over and over.Took 60 minutes to boot up in the middle of a procedure.

• Brand Name: SPARQ ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tara mackinnon ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 5064405
• MDR Text Key: 25912416
• Report Number: 3019216-2015-00047
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/04/2015

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: Health Professional
• Device Model Number: 795090
• Device Lot Number: US81510770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2015
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1