MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BREATHING HOSE, DISPOSABLE

Catalog Number MP00361

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during use the breathing circuit disconnected on the part of the elbow of the y-piece.No injury reported.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

For investigation, 2 hose systems of type ventstar basic (p) 180 and two hose systems of type ventstar water trap (p) 180 were provided.Based on the available circuits, the reported symptoms could not be comprehended.For all four systems, the angular connector was firmly connected to the y-piece or could be firmly connected to it.Since according to the instructions for use all connections must be checked for correct fit and tightness before use, a possibly too loose connection is detected and can be fixed by re-fitting.As the hose systems were already used in the hospital, no further tests such as leakage, extraction or cone testing could be carried out in order to avoid possible contamination of the test equipment.Since the angular connectors are manually assembled with the y-piece during production, it is conceivable for isolated cases that during this process there was a deviation of the applied force, which may have been root cause for the reported loose connection.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: BREATHING HOSE, DISPOSABLE
• Type of Device: BREATHING HOSE, DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9248845
• MDR Text Key: 175103431
• Report Number: 9611500-2019-00355
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP00361
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1