MAUDE Adverse Event Report: AFFINITI 70; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number AFFINITI 70 ULTRASOUND SYSTEM

Device Problems No Display/Image (1183); No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

The philips field service engineer performed an inspection and replaced the hard disk drive (hdd), the solid state drive (ssd), and reloaded the system¿s software to resolve the issue.An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.

Event Description

The customer reported an incident where their affiniti ultrasound system would hang with a delayed response while performing a biopsy.The customer was not able to see the needle at this time which required a short wait between steps to regain imaging capabilities.The procedure was completed successfully with no adverse outcome to the patient.

Manufacturer Narrative

The philips field service engineer performed an inspection and replaced the hard disk drive (hdd), the solid state drive (ssd), and reloaded the system¿s software to resolve the issue.The replaced parts were anticipated to return for detailed failure analysis, however, the drives were unable to be returned.The system has been returned to service with no similar issues reported.

• Brand Name: AFFINITI 70
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• MDR Report Key: 11499417
• MDR Text Key: 241504046
• Report Number: 3019216-2021-10032
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFFINITI 70 ULTRASOUND SYSTEM
• Device Catalogue Number: 795210
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2020
• 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