MAUDE Adverse Event Report: AMSINO HEALTCARE USA INC. AMSINO; USP STERILE WATER FOR INHALATION 550 ML HUMIDIFIER BOTTLES

Model Number AS0552E

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2023

Event Type  malfunction  

Event Description

Tab of the product for the oxygen tubing does not open.Water comes out at the top.The patient's oxygen supply was interrupted.

Manufacturer Narrative

Event ocurred in europe - germany.

• Brand Name: AMSINO
• Type of Device: USP STERILE WATER FOR INHALATION 550 ML HUMIDIFIER BOTTLES
• Manufacturer (Section D): AMSINO HEALTCARE USA INC.; 330 corporate woods parkway; vernon hills 60061
• Manufacturer Contact: esteban encarnacion ; 330 corporate woods pkwy; vernon hills, IL 60061 ; 8473831416
• MDR Report Key: 18773298
• MDR Text Key: 336991111
• Report Number: 1417519-2024-00004
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PREAMMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AS0552E
• Device Catalogue Number: AS552E
• Device Lot Number: H858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2022
• 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