MAUDE Adverse Event Report: SIMCON INTERNATIONAL LLC CUBESCAN; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number BIOCON-700

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Unit bladder scanner reading inaccurate amounts.Patient was scanned pre void and after void.Readings were not accurate with how much patient was actually voiding.When using a different bladder scan from a different unit the scanned amount was twice the amount that the original bladder scanner was reading.

• Brand Name: CUBESCAN
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): SIMCON INTERNATIONAL LLC; 1200 townline road; mundelein IL 60060
• MDR Report Key: 16408506
• MDR Text Key: 309889490
• Report Number: 16408506
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIOCON-700
• Device Catalogue Number: BIOCON-700
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Female