FDA Adverse Event
Injury
Summary report: N
REVEL
MDR report key: 3771192
·
Received April 24, 2014
Report
- Report Number
- 2031702-2014-00108
- Event Type
- Injury
- Date Received
- April 24, 2014
- Date of Event
- March 27, 2014
- Report Date
- April 24, 2014
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- PMA / PMN Number
- K070594
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CREW SET UP THE VENTILATOR FOR TRANSPORT AND IT STOPPED VENTILATING THE (RSV INTUBATED) PATIENT. THE PATIENT HAD NO CHEST RISE AND NO WAVE FORM WAS PRESENT. THE CREW TURNED THE VENTILATOR OFF AND REPROGRAMMED IT BUT IT WOULD STOP GIVING BREATHS AGAIN. THEY DID NOT WANT TO PUT THE VENTILATOR ON PEDS MODE BECAUSE THE TIDAL VOLUME ONLY WENT DOWN TO 120 AND THE PATIENT ALREADY HAD A PNEUMO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250197 | REVEL | VENTILATOR, CONTINUOUS | CBK | CAREFUSION 203, INC | 19260-001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO |