MAUDE Adverse Event Report: AFFINITI 30; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	AFFINITI 30 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the suspect control panel will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
The customer reported an incident where the swivel mechanism of their affiniti ultrasound system¿s control panel would not function properly.It could not be determined if the problem was identified while the system was stationary or in transit.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.
Event or Problem Description
The customer reported an incident where the swivel mechanism of their affiniti ultrasound system¿s control panel would not function properly.It could not be determined if the problem was identified while the system was stationary or in transit.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.
Additional Manufacturer Narrative
The customer¿s philips service engineer arrived onsite and found the reported problem to be associated with the system¿s monitor arm and not the control panel.The service engineer replaced the monitor arm to resolve the immediate issue.The suspect monitor arm was inadvertently scrapped prior to its return to philips for evaluation.Therefore, no failure or root cause analysis of the part could be performed.The root cause of the failure could not be determined.H3 other text: scrapped in field.

• Brand Name: AFFINITI 30
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 10680974
• Report Number: 3019216-2020-00104
• Device Sequence Number: 2757586
• Product Code: IYN
• UDI-Device Identifier: 00884838074187
• UDI-Public: 00884838074187
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160807
• Number of Events Summarized: 1
• Summary Report (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: AFFINITI 30 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795218
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/04/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/13/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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