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

Model Number 989605414121

Device Problem Positioning Problem (3009)

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

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

A thorough evaluation of the x7-2t model transducer identified extensive damage to the device.Performance testing revealed a failed articulation check.Examination of the transducer noted an alignment issue with the bending neck caused by structural damage to the bending neck link.Further evaluation under a microscope found that the teeth of this link had been warped which ultimately caused the reported articulation failure.Given the warping of these teeth and the apparent damage to the next link, the bending neck was likely subjected to significant force to deform the metal.These findings are indicative of improper handling and maintenance.

• Brand Name: TRANSDUCER X7-2T
• Type of Device: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 7286068
• MDR Text Key: 100673331
• Report Number: 3019216-2018-00012
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605414121
• Device Lot Number: B275MW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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