MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC IE 33 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number 795052

Device Problem Computer Operating System Problem (2898)

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

Event Type  malfunction  

Manufacturer Narrative

The cause of the issue was traced to a failed front plane and acquisition power supply.Replacing these parts resolved the issue.The failed parts have been disposed of by the customer and will not return for failure analysis.A review of our reliability data shows that no systemic trends exist for these parts.The cause of the issue was traced to a failed front plane and acquisition power supply.Replacing these parts resolved the system issue.The failed parts were discarded by the customer; therefore, no additional failure analysis can be performed.

Event Description

A customer reported an incident where their ie33 ultrasound system would not boot up for use as image guidance in an emergency procedure for a dissected aorta.Another ultrasound system was brought in and the procedure was successfully completed.There was no patient or user harmed as a result of the delay.

• Brand Name: IE 33 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 7271911
• MDR Text Key: 100146128
• Report Number: 3019216-2018-00011
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795052
• Device Lot Number: 034VMF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1