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

Model Number MD-6000

Patient Problem Urinary Tract Infection (2120)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

The portascan bladder scanners do not give accurate readings.The bladder scanner noted 469ml of urine at 01:03 but a straight catheterization produced 700ml of urine.This happened again the next day at 00:13 when the scan was 176ml, but a straight catheterization produced 525ml of urine.We noted these inaccurate equipment readings when we reviewed this chart for a catheter-associated urinary tract infection (cauti) event, and in speaking with staff, the portascan machines are notorious for this issue.We had healthcare technology management (htm) assess all of the inpatient portascan machines and within 24 hours they said they all function correctly.But they don't.We've tried to reach out to the representative for the past several months with no response.We suspect it's because our hospital system has already opted to switch to the verathon bladder scanner going forward.In our hospital, we aren't able to get the new verathon machines until the lifespan of the portascan is up, which is in 4 years, but this is a safety issue.The readings aren't just a few mls off--they're over 200 mls off.The functional human bladder holds about 300ml comfortably.

• Brand Name: PORTASCAN BLADDER SCANNER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): MEDA CO., LTD; 100 tarragona breeze ave; las vegas NV 89138
• MDR Report Key: 18658123
• MDR Text Key: 334758068
• Report Number: 18658123
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

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 Operator: Health Professional
• Device Model Number: MD-6000
• Device Catalogue Number: MD-6000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1