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

Model Number TRANSDUCER X8-2T

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer visited the customer site.He could not reproduce the articulation issue as described by the customer.After thorough inspection and testing, the transducer passed all tests and was found to be functioning as designed.The transducer was put back into use with no additional service required.No trouble found during onsite testing.

Event Description

A customer reported an x8-2t model transducer had an articulation issue preventing forward and backward motion.There was no injury associated with this event.

• Brand Name: X8-2T
• Type of Device: X8-2T
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 10641424
• MDR Text Key: 210193948
• Report Number: 3019216-2020-00101
• 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: 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: 09/10/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2020
• 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