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

Model Number 989605350451

Device Problems Crack (1135); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported that a number of patients in the intensive care unit were found to have bacteria in their throat for a couple of days.The customer stated that the only common factor shared between these patients was the same x7-2t model transducer used in each of their exams suggesting bacterial contamination.An initial visual inspection under a microscope performed by the hospital¿s internal department of hygiene and infection prevention identified minute cracks in the transducer.The suspect transducer has been removed from service and was replaced with a new x7-2t model probe.No further information regarding patient condition could be obtained at this time.

Manufacturer Narrative

A thorough evaluation of the x7-2t model transducer identified extensive damage to the device.The transducer examination noted a missing film used to protect the acoustic window, a damaged rtv bead, holes in the articulation cover to tip shell epoxy bead, and a cut in the articulation cover.The location and type of damage identified would allow for the ingress of amino acid protein based debris.The exact root cause of the damage could not be determined, however, these findings are indicative of improper handling and maintenance.

• Brand Name: X7-2T TRANSDUCER (MTEE)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 6751625
• MDR Text Key: 81482596
• Report Number: 3019216-2017-00026
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605350451
• Device Lot Number: B02J3C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2011
• 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