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

Model Number	BM432
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A customer reported an affiniti 50 ultrasound system¿s control panel articulation arm assembly broke at the system attachment point.The control panel did not fall, and no user or patient was injured as a result of this event.The control panel was replaced to resolve the immediate issue.The system was placed back into service with no additional issues reported post repair.
Event or Problem Description
A customer reported an affiniti 50 ultrasound system¿s control panel articulation arm assembly broke at the system attachment point.The control panel did not fall, and no user or patient was injured as a result of this event.The control panel was replaced to resolve the immediate issue.The system was placed back into service with no additional issues reported post repair.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the screw failure was caused by forces outside of the range of system design specifications.The system was performing as intended.No additional events regarding this issue have been reported by the customer post repair.

• Brand Name: AFFINITI 50 ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 11913878
• Report Number: 3019216-2021-10067
• Device Sequence Number: 11116158
• Product Code: IYN
• UDI-Device Identifier: 00884838097759
• UDI-Public: 00884838097759
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• 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: BM432
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/20/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 10/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2020
• 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