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

Model Number BIOCON-900

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2022

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a follow-up report will be submitted.

Event Description

It was reported that the staff plugged in device and they said it spared and looks like there was smoke.

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 Description

It was reported that the staff plugged in device and they said it sparked and looks like there was smoke.

• Brand Name: CUBESCAN
• Type of Device: 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
• MDR Text Key: 298474320
• Report Number: 3007740628-2022-00001
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 08809458500009
• UDI-Public: (01)08809458500009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIOCON-900
• Device Catalogue Number: MDSB10900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1