MAUDE Adverse Event Report: VENTSTAR; BREATHING HOSE, DISPOSABLE

Catalog Number MP00333

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

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 detached from the breathing hose during use on a patient.There was no injury reported.

Event Description

It was reported that the y-piece detached from the breathing hose during use on a patient.There was no injury reported.

Manufacturer Narrative

The affected breathing circuit was available for investigation.The reported problem of a detached y-piece could be confirmed.Further analyses have shown that the y-piece did not conform to specification due to wear and tear of the respective tool.A random sample from stock was inspected.It was found, that out of (b)(4) samples did not withstand the specified load test.Since it could not be determined when the wear and tear began to impact the strength of the adhesive joint, it was assumed that all circuits in the field may be affected.A capa was opened to initiate and document further measures.Dräger finally decided that all customers of dräger neo disposable breathing systems shipped during the last 3 years have already been/will be informed with a field safety notice which provides a description of the identified risk and advice how carefully check the devices prior to use.In the meantime the tool has been re-worked, so that new y-pieces are manufactured according to specification.In addition the gluing process has also been improved with more strict requirements regarding location and amount of the applied adhesive.

• Brand Name: VENTSTAR
• Type of Device: BREATHING HOSE, DISPOSABLE
• MDR Report Key: 10777176
• MDR Text Key: 224441385
• Report Number: 9611500-2020-00395
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP00333
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1