MAUDE Adverse Event Report: IE33 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	8500-0082-01
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the suspect transducer is anticipated.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 an x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
A philips service engineer replaced the involved transducer on the ultrasound system.Evaluation of the suspect transducer was performed upon its return from the customer.Functional testing of the transducer confirmed the articulation issue as described by the customer.An internal inspection found a twisted, kinked, and torn cable to be the root cause of the lack of articulation.Visual inspection of the returned transducer found chips on the connector, a worn i-tube, bite marks on the i-tube, chips in the beading, and blisters on the window.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.
Event or Problem Description
A customer reported an x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.

• Brand Name: IE33 ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• MDR Report Key: 11047809
• Report Number: 3019216-2020-00121
• Device Sequence Number: 1307899
• Product Code: IYN
• UDI-Device Identifier: 00884838061668
• UDI-Public: 00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• 2 Devices were Involved in the Event: 1 2

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: 8500-0082-01
• Device Catalogue Number: 795052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Distributor Facility Aware Date: 11/30/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2011
• 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