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

Model Number DIAGNOSTIC ULTRASOUND SYSTEM (795210)

Device Problems Unintended System Motion (1430); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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 the swivel mechanism of their affiniti 70 ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.The system repair is in progress.There was no injury to user or patient.

Event Description

The customer reported the swivel mechanism of their affiniti 70 ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.The system repair is in progress.There was no injury to user or patient.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue.However, due to insufficient information and part returns, the engineering team was unable to determine the root cause of this failure.The handle trigger was replaced and a mechanical adjustment was made to the arm mechanism to resolve the issue.No additional similar problems have been reported post repair.Actions are underway to ensure the necessary information and parts are received to further investigate if this issue does recur.

• Brand Name: AFFINITI 70
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 11050302
• MDR Text Key: 225778793
• Report Number: 3019216-2020-00127
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: 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,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: DIAGNOSTIC ULTRASOUND SYSTEM (795210)
• Device Catalogue Number: 795210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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