MAUDE Adverse Event Report: CARESONO TECHNOLOGY CO., LTD. BLADDER CANCER; SYSTEM, IMAGING, PULSED ECHIO, ULTRASONIC

Model Number PADSCAN HD5

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/10/2019

Event Type  malfunction  

Event Description

Machine does not produce consistent results.Fda safety report id# (b)(4).

• Brand Name: BLADDER CANCER
• Type of Device: SYSTEM, IMAGING, PULSED ECHIO, ULTRASONIC
• Manufacturer (Section D): CARESONO TECHNOLOGY CO., LTD.
• MDR Report Key: 9197195
• MDR Text Key: 162674410
• Report Number: MW5090413
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PADSCAN HD5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1