MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X7-2T; ULTRASOUND

Model Number	989605414121
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the x7-2t model transducer and additional patient outcome information will be included in a follow up report upon the probe¿s return and investigation completion.
Event or Problem Description
A customer reported their x7-2t model transducer would not produce an image during a diagnostic procedure.(b)(4) later provided additional details noting the patient needed to stop taking anticoagulants for the exam, and the delay in treatment created an embolism risk for the patient.The suspect transducer has been replaced to resolve the issue.The feedback details do not allege that any harm came to the patient as a result of the incident.
Additional Manufacturer Narrative
The customer confirmed that the patient was not harmed as a result of the issue.A backup ultrasound system was used to successfully complete the examination.Evaluation of the x7-2t model transducer identified damage to the cable and performance testing revealed a failed image test resulting in an error message.The evaluation also concluded the issue observed in the field was caused by the damaged cable.This cable was replaced to repair the device to full functionality.The exact cause of the damage could not be determined, however, philips concludes that this is not a manufacturing or design based defect and is indicative of improper maintenance.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 X7-2T
• Common Device Name: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8405223
• Report Number: 3019216-2019-00011
• Device Sequence Number: 13899659
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K030455
• 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): 01/17/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 989605414121
• Device Lot Number: B20BZM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0