MAUDE Adverse Event Report: BREATHING HOSE, DISPOSABLE; BREATHING HOSE , DISPOSABLE

Catalog Number MP02721

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the y-piece disconnected during use resulting in an interruption of gas delivery to the patient.There was no injury reported.

Event Description

It was reported that the y-piece disconnected during use resulting in an interruption of gas delivery to the patient.There was no injury reported.

Manufacturer Narrative

Unfortunately, the affected hose system was not available anymore at customer site so that it could not be provided for investigation.Therefore, a case-specific evaluation was not possible and the root cause for the reported disconnection could not be determined.As the affected connection between tube and y-piece is a plug connection the ifu describes as a warning that before use it has to be confirmed that all connections are secure and free of leakages.In line with this pre-use check a loose plug connection is detected and can be reconnected properly.If a relevant leakage occurs due to a loose connection, it will be detected during the leak-test that must be performed prior to each patient use.In case a relevant leakage suddenly occurs during use, corresponding alarms will be given.

• Brand Name: BREATHING HOSE, DISPOSABLE
• Type of Device: BREATHING HOSE , DISPOSABLE
• MDR Report Key: 11391702
• MDR Text Key: 243834030
• Report Number: 9611500-2021-00092
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP02721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1