MAUDE Adverse Event Report: VERATHON MEDICAL BLADDERSCAN BVI 6100; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 0570-0154

Device Problems Smoking (1585); Explosion (4006)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The ac/dc power supply adapter was returned to verathon for evaluation.A verathon technical service representative evaluated the returned ac/dc power supply adapter and confirmed the fire or explosion.The technician noted that a loose part inside the power supply caused the explosion.The ac/dc power supply adapter was scrapped.No corrective action is required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that when the unit was put on the charger, the ac/dc power supply adapter made an explosion noise and started smoking.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: BLADDERSCAN BVI 6100
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VERATHON MEDICAL; 20001 n creek pkwy; bothell, wa
• Manufacturer (Section G): VERATHON MEDICAL; 20001 n creek pkwy; bothell, wa
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, wa ; 6295760
• MDR Report Key: 9936532
• MDR Text Key: 187549799
• Report Number: 3022472-2020-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K022153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0154
• Device Catalogue Number: 0570-0154
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• 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