MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CX50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number CX50 ULTRASOUND SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/26/2024

Event Type  Injury  

Event Description

A serious injury was reported when a 51-year-old patient came back to the hospital with complaints of dysphagia and odynophagia, a week after having undergone a cardiac surgery using an x7-2t transducer and a cx50 ultrasound system.An endoscopy was performed verifying a 4-5 cm longitudinal mucosal esophageal laceration.The patient was rehospitalized to provide medical care of esophageal fibroscopy, three times along with strict fasting with parenteral nutrition.The customer reported the surgery was five hours in length, in which the x7-2t transducer was left in place in the patient¿s esophagus.There was no report of the transducer malfunctioning during the procedure and the transducer is currently in use at the facility.The customer reported the injury could be related to pressure from the transducer being indwelling during the procedure but could not rule out a mechanical event.An investigation is underway to determine the root cause of the issue.The results of the investigation will be included in a follow-up report upon its completion.

• Brand Name: CX50
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 18867811
• MDR Text Key: 337244380
• Report Number: 3019216-2024-00032
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CX50 ULTRASOUND SYSTEM
• Device Catalogue Number: 795045
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 1 MO