MAUDE Adverse Event Report: PHILIPS ULTRASOUND X8-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number TRANSDUCER X8-2T

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

After a thorough inspection and testing of the suspect transducer, the philips service engineer was unable to duplicate the failure and determined it was functioning properly.The customer had also continued to use this transducer after the reported failure without any further issues.As the transducer remains in service with no return anticipated, no further failure analysis can be performed.Worked as expected during testing.

Event Description

A customer reported an x8-2t model transducer would not articulate with hand controls during use.There was no injury associated with this event.

• Brand Name: X8-2T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 11158791
• MDR Text Key: 226550781
• Report Number: 3019216-2021-00005
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: 00884838069718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: TRANSDUCER X8-2T
• Device Catalogue Number: 989605455171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/23/2020
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1