MAUDE Adverse Event Report: AMSINO HEALTHCARE USA INC. AMSINO AMSURE; HUMIDIFIER

Model Number AS0352E

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

Attempt has been made to collect more information from the customer.

Event Description

Faulty humidification system for administering oxygen.When connected to an oxygen reducer, the container increases in volume, squeaks and explodes.

• Brand Name: AMSINO AMSURE
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): AMSINO HEALTHCARE USA INC.; 330 corporate woods pkwy; vernon hills IL 60061
• Manufacturer (Section G): AMSINO HEALTHCARE; 330 corporate woods pkwy; vernon hills IL 60061
• Manufacturer Contact: esteban encarnacion ; 330 corporate woods pkwy; vernon hills, IL 60061 ; 8473831416
• MDR Report Key: 18937657
• MDR Text Key: 338189574
• Report Number: 1417519-2024-00005
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: AS0352E
• Device Lot Number: J896
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White