MAUDE Adverse Event Report: PHILIPS ULTRASOUND X7-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number TRANSDUCER X7-2

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

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 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: X7-2T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11341859
• MDR Text Key: 232338427
• Report Number: 3019216-2021-10017
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TRANSDUCER X7-2
• Device Catalogue Number: 989605414122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 01/20/2021
• Event Location: No Information
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse