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

Model Number	AFFINITI 50 ULTRASOUND SYSTEM
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	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Initially this event was thought to be a control panel swivel unlocking.It was later determined to be a monitor arm detachment.It was reported the affiniti 50 ultrasound system had a broken and detached monitor arm.The system was not in clinical use at the time and no person was harmed.The field service engineer (fse) replaced the monitor arm.
Additional Manufacturer Narrative
Upon investigation by philips, the customer reported the monitor was tilted down with pressure and the monitor tilt/swivel arm broke.This site is serviced by an authorized philips distributor and, to resolve the reported issue, the monitor arm was replaced.Further analysis of the replaced part was not possible, as the replaced part was discarded.Philips performed failure analysis of the same part model and determined that the amount of weight needed to cause a similar failure would need to exceed the weight of the attached monitor and would require a significant amount of added force.At this time based on the available information, we are unable to determine if the pressure applied to the monitor tilt was outside normal expected use.H3 other text : not returned.
Additional Manufacturer Narrative
Upon investigation by philips, the customer reported the monitor was tilted down with pressure and the monitor tilt/swivel arm broke.This site is serviced by an authorized philips distributor and, to resolve the reported issue, the monitor arm was replaced.Further analysis of the replaced part was not possible, as the replaced part was discarded.Philips performed failure analysis of the same part model and determined that the amount of weight needed to cause a similar failure would need to exceed the weight of the attached monitor and would require a significant amount of added force.At this time based on the available information, we are unable to determine if the pressure applied to the monitor tilt was outside normal expected use.H3 other text: not returned.

• Brand Name: AFFINITI 50
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16744689
• Report Number: 3019216-2023-00046
• Device Sequence Number: 17776953
• Product Code: IYN
• UDI-Device Identifier: 00884838056244
• UDI-Public: 00884838056244
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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: AFFINITI 50 ULTRASOUND SYSTEM
• Device Catalogue Number: 795208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 03/17/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/02/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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