InjuryBTC
VENTSTAR HELIX
Received Jan 17, 2019 · Event occurred Jan 4, 2019
Report 9611500-2019-00014 · MDR key 8256214
Device
Generic name
Breathing Hose, Disposable
Manufacturer
Drägerwerk Ag & Co. KgaaModel number
NACatalog number
MP02607
Lot number
NA
Product problems
- Crack
Patient
Not reported
- Bradycardia
- Cardiopulmonary Arrest
- Bradycardia
- Cardiopulmonary Arrest
Narrative
Additional Manufacturer Narrative
THIS CASE HAS BEEN REPORTED WRONGLY TO THE FDA. THE AFFECTED BREATHING HOSE DOES NOT HAVE A US APPROVAL.
Description of Event or Problem
PLEASE REFER TO THE INITIAL-REPORT.
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.
Description of Event or Problem
IT WAS REPORTED THAT A CRACK WAS FOUND IN THE BREATHING CIRCUIT. THE PATIENT DEVELOPED DESATURATION FOLLOWED BY BRADYCARDIA AND CARDIAC ARREST. CPR WAS DONE AND PATIENT REVIVED.