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

Lot Number B1BD63

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

The cardiac exam was completed successfully and no additional patient treatment or medical intervention was required post procedure.

Event Description

A customer reported detecting a gastric rupture during a cardiac examination using an x7-2t model transducer with an epiq ultrasound system.Endoscopic hemostasis was required to manage the rupture.No further intervention or additional treatment was required.

Manufacturer Narrative

The cardiac exam was completed successfully and no additional patient treatment or medical intervention was required post procedure.The involved transducer was not replaced and is currently in use without additional reported issues.The involved transducer was not replaced and is currently in use without additional reported issues.

• 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: tara mackinnon ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6523761
• MDR Text Key: 73785243
• Report Number: 3019216-2017-00011
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: B1BD63
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• 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