MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC IU22 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 795050

Device Problems Fire (1245); Device Emits Odor (1425); Computer Operating System Problem (2898)

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

Event Type  malfunction  

Manufacturer Narrative

Return of the umb is anticipated.Evaluation of this part will be included in a follow up report upon its return and investigation completion.

Event Description

A customer reported an iu22 ultrasound system would not boot up and produced a component failure odor.During servicing, the philips field service engineer observed a flame in the component compartment which was extinguished by unplugging the system.There was no injury associated with this event.The umb was identified as the cause of the system failure.This part was replaced to repair the system which remains at the customer site.

Manufacturer Narrative

Evaluation of the returned umb identified a burnt connector between the motherboard and uavio.A short circuit at this failure point was determined to be the root cause of the component failure odor and flame.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: IU22 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8931593
• MDR Text Key: 155622759
• Report Number: 3019216-2019-00059
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K042540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795050
• Device Lot Number: 02X3NX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1