MAUDE Adverse Event Report: MEDA CO., LTD BLADDER SCANNER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	MD-6000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bladder scanner was used on patient to assess for retention.Bladder scanner showed volumes between 600-800mls.Foley was to be placed for patient.When foley was placed there was no output.3 separate nurses attempted to insert foley in order to get urine output.Nurse went to cross reference with another bladder scanner on unit before urology needed to be consulted.The second bladder scanner showed volume of 153.

• Brand Name: BLADDER SCANNER
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): MEDA CO., LTD; 13505 broadfield drive; potomac MD 20854
• MDR Report Key: 14799259
• Report Number: 14799259
• Device Sequence Number: 5812768
• Product Code: ITX
• 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): 06/10/2022
• Report Date (Section F): 06/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: MD-6000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 06/10/2022