MAUDE Adverse Event Report: MEDA CO., LTD BLADDER SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	MD-6000
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came into the department complaining of urinary retention.Bladder scan was ordered and performed however the bladder scanner was not reading accurate results.

• Brand Name: BLADDER SCANNER
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): MEDA CO., LTD; 100 tarragona breeze ave,; las vegas NV 89138
• MDR Report Key: 20256029
• Report Number: 20256029
• Device Sequence Number: 7979870
• Product Code: IYO
• UDI-Device Identifier: 06948941160008
• UDI-Public: (01)06948941160008
• 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): 06/12/2024
• Report Date (Section F): 06/12/2024

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
• Device Model Number: MD-6000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/12/2024