MAUDE Adverse Event Report: VERATHON INC. BLADDERSCAN®; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number BVI 9400

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Found user damaged bladder scanner on patient floor.This device will be sent out to the oem for repair and calibration.

• Brand Name: BLADDERSCAN®
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON INC.; 20001 north creek pkwy; bothell WA 98011
• MDR Report Key: 6759968
• MDR Text Key: 81601786
• Report Number: 6759968
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BVI 9400
• Device Catalogue Number: 0570-0193
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/04/2017
• Date Report to Manufacturer: 07/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1