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

Model Number Spectra S1 plus

Device Problem Fire (1245)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 304273913
• Report Number: 3011139154-2022-00002
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 08809108011091
• UDI-Public: (01)08809108011091(11)210909
• Combination Product (y/n): N
• PMA/PMN Number: K150476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Spectra S1 plus
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female