MAUDE Adverse Event Report: PHILIPS ULTRASOUND CLEARVUE 650; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	989605414681
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	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a clearview 650 ultrasound system¿s monitor detached from the articulation arm assembly.The mounting arm screws were replaced and tightened to repair the system.There was no injury associated with this event.
Additional 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.
Additional Manufacturer Narrative
The philips field service engineer (fse) found the loose connection and the mounting arm screws were replaced and tightened to repair the system.The fse tested the function of the arm and passed.Since the articulation arm assembly was not replaced evaluation of this part was not performed.The system has returned to service with no further report of this issue.

• Brand Name: CLEARVUE 650
• Common Device Name: 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: 14854072
• Report Number: 3019216-2022-00066
• Device Sequence Number: 4908909
• Product Code: IYN
• UDI-Device Identifier: 00884838033443
• UDI-Public: 00884838033443
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K120321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 989605414681
• Device Catalogue Number: 795220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2014
• 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