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

Lot Number US815F1125

Device Problems Thermal Decomposition of Device (1071); Fumes or Vapors (2529); Flare or Flash (2942)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the acquisition control pcba will be included in a follow up report upon its return and investigation completion.

Event Description

A customer reported their affiniti ultrasound system produced a burning odor and flame from the base of the control panel.The ultrasound system was promptly powered down and the power cord removed from the wall outlet which terminated the immediate problem.No patient or user was harmed as a result of the issue.The site¿s local service engineer inspected the system and identified a burnt component within the acquisition control board.No additional evidence of a fire having occurred or damage to the system was found.After replacing the failed board, the system was tested, verified as operational and returned to service.

Manufacturer Narrative

Evaluation of the acquisition control pcba confirmed the condition as described by the customer.The investigation traced the source of the failure to a defective capacitor within the board.After performing an extensive evaluation of the pcba, the cause of the component¿s failure could not be determined.The pcba was repaired by replacing the defective capacitor.

• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7898398
• MDR Text Key: 121565874
• Report Number: 3019216-2018-00045
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: US815F1125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1