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

Model Number BVI 9400

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Event 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®
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON, INC; 20001 north creek pkwy; bothell WA 98011
• MDR Report Key: 7663550
• MDR Text Key: 113186341
• Report Number: 7663550
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00879123001948
• UDI-Public: (01)00879123001948
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BVI 9400
• Device Catalogue Number: 0620-0340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1