MAUDE Adverse Event Report: MCUBE TECHNOLOGY CO., LTD. CUBESCAN; BLADDER VOLUME MEASUREMENT SYSTEM

Model Number	BIOCON-900
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a follow-up report will be submitted.
Event or Problem Description
It was reported that the staff plugged in device and they said it spared and looks like there was smoke.
Additional Manufacturer Narrative
It was reported that staff plugged in the device and they said it sparked and looks like there was smoke.And it was also reported that there is no patient involved in the event and the power cord and inlet of the device were replaced by a field service engineer.Mcube technology investigated the power cord and inlet and found that among the 3 pins of the inlet, the ground pin was damaged, and it was inserted into the plug.The cause of the event could not be confirmed.The power cord and inlet were ul approved and the electrical safety of the device complies with iec60601-1.
Event or Problem Description
It was reported that the staff plugged in device and they said it sparked and looks like there was smoke.

• Brand Name: CUBESCAN
• Common Device Name: BLADDER VOLUME MEASUREMENT SYSTEM
• Manufacturer (Section D): MCUBE TECHNOLOGY CO., LTD.; 39, magokjungang 12-ro; gangseo-gu; seoul, 07789 ; KS 07789
• Manufacturer (Section G): MCUBE TECHNOLOGY CO., LTD.; 39, magokjungang 12-ro; gangseo-gu; seoul, 07789 ; KS 07789
• Manufacturer Contact: changhyun kim ; 39, magokjungang 12-ro; gangseo-gu; seoul, 07789 ; KS 07789
• MDR Report Key: 14048423
• Report Number: 3007740628-2022-00001
• Device Sequence Number: 14605753
• Product Code: IYO
• UDI-Device Identifier: 08809458500009
• UDI-Public: (01)08809458500009
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: BIOCON-900
• Device Catalogue Number: MDSB10900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown