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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MCUBE TECHNOLOGY CUBESCAN BIOCON-750; TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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MCUBE TECHNOLOGY CUBESCAN BIOCON-750; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 750
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2019
Event Type  malfunction  
Event Description
New bladder scanner medline model biocon750 kept showing zero ml, but we kept trying and at one point the rn got a scan saying >999ml.Two rns kept trying to scan and all subsequent (approximately 10 tries from various angles) readings were 0ml.We attempted to find the old (preferred) bladder scanner but could not.Rns analyzed symptoms and prior ct showing bladder distention and got an order to straight cath from hospitalist.After four failed attempts the 5th catheter placement was successful with >2l urine output in the first 30 minutes.Either the new bladder scanner is not good or rn training is inadequate to operate.
 
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Brand Name
CUBESCAN BIOCON-750
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
MCUBE TECHNOLOGY
simcon international llc
1200 townline road
mundelein IL 60060
MDR Report Key8845177
MDR Text Key152783210
Report Number8845177
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/08/2019,05/14/2019
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 No Information
Device Model Number750
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2019
Date Report to Manufacturer07/31/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age15695 DA
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