MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 70 - 795210; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 989605416151

Device Problem Computer Operating System Problem (2898)

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

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer inspected the suspect ultrasound system at the customer site.Examination of the system logs revealed corrupt data within the system software.Upgrading the ultrasound system to the latest software version resolved this issue and the system was returned to clinical use with no additional issues reported post software upgrade.

Event Description

A customer reported an affiniti 70 ultrasound system crashed during a diagnostic scan prior to a cardiac procedure.Another ultrasound was used for diagnostic scanning and the imaging limitation did not affect clinical judgment or patient outcome.The procedure was completed successfully and there was no injury associated with this event.

• Brand Name: AFFINITI 70 - 795210
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, 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: 9492206
• MDR Text Key: 177219690
• Report Number: 3019216-2019-00092
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: (01)00884838056251
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605416151
• Device Lot Number: US719F1762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2019
• 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