MAUDE Adverse Event Report: PHILIPS ULTRASOUND CX50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	989605384711
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the suspect hard drive and ebox is anticipated.Evaluation of these parts will be included in a follow-up report upon its return and investigation completion.
Event or Problem Description
A customer reported their cx50 ultrasound system displayed a blank screen and shut down during use with a patient in an unstable condition.The type of procedure being performed is unknown at this time.A philips service engineer replaced the hard drive and ebox to repair the system.There was no allegation of altered patient outcome as a result of the issue.
Additional Manufacturer Narrative
A philips field service engineer performed a thorough inspection of the cx50 ultrasound system and determined the reported issue was caused by a failed e-box assembly and hard drive.The service engineer repaired the system by replacing the e-box assembly, hard drive and reloading the system software.The e-box assembly had a defective morpheus board that required replacement.The hard drive was inadvertently discarded prior to returning for evaluation; therefore, no additional failure analysis could be performed.The system has returned to service.
Additional Manufacturer Narrative
The previously submitted follow up report omitted the evaluation method codes, evaluation results code and the conclusion code.Submitting additional information with the evaluation method codes, evaluation results codes and the conclusion codes.

• Brand Name: CX50
• Common Device Name: 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: 13656637
• Report Number: 3019216-2022-00023
• Device Sequence Number: 11229872
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: 00884838025295
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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: 989605384711
• Device Catalogue Number: 795087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 02/18/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 10/13/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2019
• 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