MAUDE Adverse Event Report: UZINMEDICARE CO., LTD. SPECTRA S1 PLUS; PUMP, BREAST, POWERED

Model Number	Spectra S1 plus
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that product has a fire.No adverse patient effects were reported.The result of reviewing the cause of the product fire is presumed that the battery was fired.

• Brand Name: SPECTRA S1 PLUS
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): UZINMEDICARE CO., LTD.; 56, dongtansandan 5-gil; hwaseong-si; gyeonggi, 18487 ; KS 18487
• Manufacturer (Section G): UZINMEDICARE CO., LTD.; 56, dongtansandan 5-gil; hwaseong-si; gyeonggi, 18487 ; KS 18487
• Manufacturer Contact: jieun lee
• MDR Report Key: 15864034
• Report Number: 3011139154-2022-00002
• Device Sequence Number: 5994086
• Product Code: HGX
• UDI-Device Identifier: 08809108011091
• UDI-Public: (01)08809108011091(11)210909
• Combination Product (Y/N): N
• PMA/510(K) Number: K150476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/25/2022

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: Lay User/Patient
• Device Model Number: Spectra S1 plus
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Female