MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T

Model Number	989605455171
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 their x8-2t model transducer had a loss of articulation movement one direction.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer confirmed the articulation issue as described by the customer.Investigation of the device revealed a worn i-tube, a hole in the sheath, debris on the sheath, and damage to the cable jacket and connector.Additional inspection found a burr beside the hinge frame which caused damage to the internal cabling and effected the articulation.Although the cause of the burr could not be determined, assembly procedures include the evaluation and removal of burrs after completion of the manufacturing process to prevent occurrences of this anomaly.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: TRANSDUCER X8-2T
• Common Device Name: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9492216
• Report Number: 3019216-2019-00093
• Device Sequence Number: 2897794
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K163120
• 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
• Report Date (Section B): 12/04/2019

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: 989605455171
• Device Lot Number: B2B8WK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1