MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7G - 795200; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22

Model Number EPIQ 7G - 795200

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The ultrasound system was inspected and tested at the customer site.Inspection identified several damage components which were replaced to repair the system.The system resumed normal operation and passed functional testing after service.The damaged parts are being returned to philips for evaluation.Evaluation results will be included in a follow up report upon return and investigation completion.

Event Description

A customer reported an epiq 7g ultrasound system started smoking during a patient examination.The examination in progress was completed without injury or adverse effects.

Manufacturer Narrative

Design engineering performed a thorough evaluation on the returned parts.The investigation determined the issue to be an isolated hardware failure where several parts within the ultrasound enclosure were damaged due to an electrical shorting condition against the sheet metal casing.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: EPIQ 7G - 795200
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10448737
• MDR Text Key: 205102585
• Report Number: 3019216-2020-00057
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: (01)00884838047693
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7G - 795200
• Device Catalogue Number: EPIQ 7G - 795200
• Device Lot Number: USO19B0989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1