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

Catalog Number MP02607

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the heating wire in the expiratory limb initiated a fire spark near the y-piece directly before the patient tube.The stuff reportedly put out the fire using a blanket and disconnected the patient.However, it was found that the patient¿s shoulders burnt due to the catching fire in the bedsheet, also slight burns in the face.

Manufacturer Narrative

This case has been reported wrongly to the fda.The affected breathing hose does not have a us approval.

Event Description

Please refer to the initial-report.

• Brand Name: VENTSTAR HELIX
• Type of Device: BREATHING HOSE, DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9743618
• MDR Text Key: 180548029
• Report Number: 9611500-2020-00052
• Device Sequence Number: 1
• Product Code: BTT
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP02607
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization