MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR FLEX 220; BREATHING HOSE DISPOSABLE

Catalog Number MP00355

Device Problems Crack (1135); Fracture (1260); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported that the hose tears/ breaks during use.No injury reported.

Event Description

It has been reported that the hose tears/ breaks during use.No injury reported.

Manufacturer Narrative

Two original packed hose systems from the lot of the affected hose system were provided, on which the reported symptom could not be reproduced.On the basis of the available photo, the reported failure pattern could be confirmed.For the affected ventstar flex 220, a crack was visible in the flex hose, located exactly on the lower edge of a fold in the hose.In the area of the fold, the load is greatest when the flex hose is pulled out, so it can be assumed that a mechanical force exceeding the normal load was the cause of the symptom.Finally the exact cause could not be determined.A relevant leakage is detected and alarmed by the connected basic unit during the pre-use check or during use.

• Brand Name: VENTSTAR FLEX 220
• Type of Device: BREATHING HOSE DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10883855
• MDR Text Key: 218649474
• Report Number: 9611500-2020-00430
• Device Sequence Number: 1
• Product Code: CAI
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP00355
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1