FDA Adverse Event
Malfunction
Summary report: N
EVITA 4
MDR report key: 3963771
·
Received May 16, 2014
Report
- Report Number
- 9611500-2014-00037
- Event Type
- Malfunction
- Date Received
- May 16, 2014
- Date of Event
- April 15, 2014
- Report Date
- May 16, 2014
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K961687
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. WE WILL PROVIDE OUR RESULTS WITHIN A SEPARATE FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED: ON (B)(6), IN THE AFTERNOON, THE EVITA 4 SUDDENLY FAILED ON AN INTUBATED PATIENT WITHOUT INDICATING A TECHNICAL FAILURE BEFORE. AS A CONSEQUENCE THE PATIENT NEEDED TO BE VENTILATED WITH AN AMBU BAG UNTIL A SUBSTITUTE DEVICE WAS AVAILABLE. ACCORDING TO THE USER THIS REPRESENTS A POTENTIAL RISK FOR THE PATIENT DUE TO THE SET POOP OF 15. THERE WAS NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293074 | EVITA 4 | VENTILATOR, INTENSIVE CARE | CBK | DRAEGER MEDICAL GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |