MAUDE Adverse Event Report: DIRECT SUPPLY MANUFACTURING INC. BLADDER SCANNER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number BRP-1

Device Problem Fire (1245)

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

Event Date 02/27/2020

Event Type  No Answer Provided  

Event Description

Bladder scanner caught on fire while charging.Fda safety report id# (b)(4).

• Brand Name: BLADDER SCANNER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): DIRECT SUPPLY MANUFACTURING INC. ; ds71; van nuys CA 91405
• MDR Report Key: 9794040
• MDR Text Key: 182212699
• Report Number: MW5093543
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BRP-1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1