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

Model Number 989605414121

Device Problem Positioning Problem (3009)

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

Evaluation of the x7-2t model transducer revealed corrosion on the connector and between the knobs on the midhandle.Performance testing of the probe verified proper function of the articulation knobs, so the reported problem could not be confirmed.However, signs of corrosion or material buildup were identified within the knob/midhandle interface which may have led to the issue observed in the field.The investigation concluded that exposure to fluid and materials over time likely resulted in the buildup and reported problem.The damage found on the probe is indicative of improper transducer care and maintenance.

• Brand Name: TRANSDUCER X7-2T
• Type of Device: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7912265
• MDR Text Key: 122006629
• Report Number: 3019216-2018-00047
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• 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
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• 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: B238TX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1