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

Model Number	AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the transducer will be included in a follow-up report upon its return and investigation completion.
Event or Problem Description
A customer reported a transesophageal echocardiogram (tee) transducer would not articulate downward on an affiniti 50 ultrasound system during use.Service for the replacement of the suspect transducer is in progress.There was no patient or user harm associated with this event.
Event or Problem Description
A customer reported a transesophageal echocardiogram (tee) transducer would not articulate downward on an affiniti 50 ultrasound system during use.Service for the replacement of the suspect transducer is in progress.There was no patient or user harm associated with this event.
Additional Manufacturer Narrative
A philips service engineer has contacted the customer to attend the site for performance testing and transducer replacement.However, the customer declined service and has decided to retain the suspect transducer.Since the transducer has not been returned for evaluation, no failure or root cause analysis of the part could be performed.The system was placed back into service at the customer site and no additional issues have been reported post notification.H3 other text: the customer declined replacing the suspect transducer.

• Brand Name: AFFINITI 50
• 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: 12283147
• Report Number: 3019216-2021-10096
• Device Sequence Number: 4599962
• Product Code: IYN
• UDI-Device Identifier: 00884838097759
• UDI-Public: 00884838097759
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• 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: AFFINITI 50 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/15/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2019
• 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