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

Model Number X8-2T

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/22/2019

Event Type  malfunction  

Event Description

A physician and technician came to discuss hole found in the end of a tee probe that was identified by a processor.It had not failed a leak test, but the damage was assumed a bite mark.They wanted to look at the process and our leak tester.It was discovered that the tester submersible conductivity probe manufacture # ult-pc-30 had created the hole in the tip of the tee probe.It has a sharp enough prong in the tester portion that it can inadvertently cause possible damage if positioned in the manner that the department was in serviced by the astra tee rep.If the tee probe is placed in the same chamber as the leak/conductivity tester as instructed, the probe can and could scrape or cause a perforation in the covering.

• Brand Name: TRANSDUCER X8-2T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 9097776
• MDR Text Key: 159411723
• Report Number: 9097776
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2019,07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: X8-2T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Date Report to Manufacturer: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1