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

Model Number	989605410251
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the articulating arm is unable to be locked on their affiniti 50 ultrasound system.It is unknown at this time if the system was mobile when failure occurred.There is no death or serious injury was reported.Philips has made multiple attempts to contact the customer for further information to no avail.If further information becomes available a supplemental report will be submitted.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.

• Brand Name: AFFINITI 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASON
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16397918
• Report Number: 3019216-2023-00018
• Device Sequence Number: 6602565
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 989605410251
• Device Catalogue Number: 795208
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 05/03/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown