MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B134ZM

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/05/2015

Event Type  Injury  

Manufacturer Narrative

Requests for more information were submitted which resulted in verification the patient¿s esophagus was resected to treat the injury.Additional details could not be obtained; serial numbers for both system and transducer involved in the incident were requested, but could not be confirmed.As a result, no failure analysis could be performed to determine the cause of the patient injury.No additional information could be obtained for this event.Additional details could not be obtained; serial numbers for both system and transducer involved in the incident were requested, but could not be confirmed.As a result, no failure analysis could be performed to determine the cause of the patient injury.

Event Description

A customer informed their local field service engineer of an event that occurred approximately two years ago involving a patient injury that had not previously been reported to philips.A month after undergoing a transesophageal (tee) procedure using philips devices, a patient claimed they suffered burns to their throat which may have been caused by the tee examination.

• 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: 7060504
• MDR Text Key: 92969653
• Report Number: 3019216-2017-00039
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: B134ZM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2014
• 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
• Patient Outcome(s): Required Intervention