FDA Adverse Event
Malfunction
Summary report: N
EVOLUTION 3E HP
MDR report key: 5169245
·
Received October 22, 2015
Report
- Report Number
- 3006135941-2015-00011
- Event Type
- Malfunction
- Date Received
- October 22, 2015
- Date of Event
- October 17, 2015
- Report Date
- October 22, 2015
- Manufacturer
- EVENT MEDICAL LTD.
- Product Code
- CBK
- PMA / PMN Number
- K113743
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MODEL (EVOLUTION 3E) IS NOT DISTRIBUTED IN THE USA.
Description of Event or Problem · 1
THE VENTILATOR TURNED OFF WHILE CONNECTED TO A PATIENT. THE BACKUP ALARM DID COME ON WHEN THE VENTILATOR SHUT OFF. WHEN THE USER TRIED TURNING THE VENTILATOR BACK ON, THE VENT SHUT OFF BEFORE THE SELF TEST COULD FINISH. I CHECKED THE BATTERIES AND NOTICED THEY WERE DRAINED ALTHOUGH THE GREEN LIGHT ON THE FRONT OF THE VENTILATOR WAS ON. WHEN I CHANGED THE POWER SUPPLY THE BATTERIES WERE CHARGING AGAIN AND EVERYTHING WAS WORKING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699639 | EVOLUTION 3E HP | CONTINUOUS VENTILATOR | CBK | EVENT MEDICAL LTD. | EVOLUTION 3E HP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |