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

Model Number 795210

Device Problem Unintended System Motion (1430)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by an engineer.The engineer adjusted the cable for the affiniti 70 ultrasound system's release handle which resolved the reported issue.The system was returned to service.No further issues were reported.

Event Description

A customer reported that their affiniti 70 ultrasound system's articulation arm was not locking in place.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.

• Brand Name: AFFINITI 70
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16365382
• MDR Text Key: 309581007
• Report Number: 3019216-2023-00015
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: 00884838056251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795210
• Device Catalogue Number: 795210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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