MAUDE Adverse Event Report: BISTOS CO., LTD. MOTIF DUO; BREAST PUMP

Model Number	MOTIF DUO
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the breast pump burned.Customer had not used the device when the device was burned.No adverse patient effects were reported.
Event or Problem Description
It was reported that the breast pump burned.Customer had not used the device when the device was burned.No adverse patient effects were reported.
Event or Problem Description
It was reported that the breast pump burned.Customer had not used the device when the device was burned.No adverse patient effects were reported.

• Brand Name: MOTIF DUO
• Common Device Name: BREAST PUMP
• Manufacturer (Section D): BISTOS CO., LTD.; 7th fl., a bldg, woolim lions; valley 5cha 302 galmachi-ro; jungwongu,seongnamsi,, gyeonggido 13201 ; KS 13201
• Manufacturer (Section G): BISTOS CO., LTD.; 104-109,115-122,; sangdaewondong sagimakgolro; seongnamsi, gyeonggido 13201 ; KS 13201
• Manufacturer Contact: hoojeong lee ; 7th fl., a bldg, woolim lions; valley 5cha 302 galmachi-ro; jungwongu,seongnamsi, gyeonggido 13201 ; KS 13201
• MDR Report Key: 18223160
• Report Number: 3006179052-2023-00003
• Device Sequence Number: 12189927
• Product Code: HGX
• UDI-Device Identifier: 00887529000151
• UDI-Public: 00887529000151
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2023

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 Model Number: MOTIF DUO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2022
• Supplement Date Received by Manufacturer: 11/20/2022; 11/20/2022
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 04/12/2024; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American