MAUDE Adverse Event Report: PHILIPS ULTRASOUND AFFINITI 50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number 989605410251

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

A customer reported the monitor arm bracket broke off of their affiniti 50 ultrasound system.A philips service engineer replaced the tilt swivel arm and touchscreen to repair the system.No patient or user was harmed as a result of the issue.The system has been returned to service with no additional issues reported.

Manufacturer Narrative

Return of the suspect tilt swivel arm assembly is anticipated.Evaluation of the arm will be included in a follow-up report upon its return and investigation completion.

Manufacturer Narrative

A thorough investigation was completed by r&d.It was determined this issue was not caused by normal operation of the system and was most likely due to sudden force to the monitor/arm most likely during transit.

• Brand Name: AFFINITI 50
• 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 15130387
• MDR Text Key: 304336092
• Report Number: 3019216-2022-00072
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132304
• 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: 989605410251
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2015
• 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