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

Model Number MD-6000

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2022

Event Type  malfunction  

Event 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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): MEDA CO., LTD; 13505 broadfield drive; potomac MD 20854
• MDR Report Key: 14799259
• MDR Text Key: 294665996
• Report Number: 14799259
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 06948941160008
• UDI-Public: (01)06948941160008
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MD-6000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Female