MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER, X7-2T (MTEE) COMPACT; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B0JY0G

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.

Event Description

A customer reported an articulation issue with their x7-2t model transducer.There was no injury associated with this event.

Manufacturer Narrative

The customer cancelled the replacement transducer order and the suspect transducer remains at the customer site.Since the device was not returned, no failure analysis could be performed.

Manufacturer Narrative

Evaluation of the transducer confirmed the articulation issue as described by the customer.Investigation of the device noted damage to the bending neck, mid-handle, connector housing, corrosion in the connector, a hole in the sheath with fluid ingress, and a frayed steering cable.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

• Brand Name: TRANSDUCER, X7-2T (MTEE) COMPACT
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7446869
• MDR Text Key: 106251295
• Report Number: 3019216-2018-00025
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B0JY0G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1