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

Model Number	BVI 9400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The bladder scanner showed 15 ml on the screen.I used it 5 times and got similar readings.Then his old foley was removed and a new one placed.A 1150 ml was immediately drained.

• Brand Name: BLADDERSCAN®
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON, INC; 20001 north creek pkwy; bothell WA 98011
• MDR Report Key: 7663550
• Report Number: 7663550
• Device Sequence Number: 2501634
• Product Code: ITX
• UDI-Device Identifier: 00879123001948
• UDI-Public: (01)00879123001948
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/12/2018
• Report Date (Section F): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BVI 9400
• Device Catalogue Number: 0620-0340
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/12/2018