FDA Adverse Event
Malfunction
Summary report: N
VELA
MDR report key: 2050319
·
Received April 6, 2011
Report
- Report Number
- MW5020209
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Manufacturer
- CAREFUSION
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE POWER SWITCH ON THE BACK OF MACHINE WAS IN "OFF" POSITION. PATIENT'S WIFE SAID SHE NOTICED THAT THE VENT WAS NOT ON. NO INJURY TO PATIENT. THE POWER SWITCH ON THE BACK OF THE MACHINE WAS SHUT OFF. PER RT, IF THE MACHINE IS HIT CORRECTLY, THE COVER CAN FLIP OPEN AND SHUT POWER OFF. THIS HAS OCCURRED BEFORE. IT IS A RARE INCIDENT. THE GUARDS ON THE VENT ARE TWO POSTS ON THE SIDE. ON THE SWITCH ITSELF, THE GUARD IS A TRIANGULAR PIECE OF LEXAN PLASTIC THAT SWIVELS ON A POST. MACHINE WAS REVIEWED BY UHS ON (B)(6) 2011 AND SHOWED NO MALFUNCTIONS AND COULD NOT DUPLICATE PROBLEM NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VELA | VENTILATOR | CBK | CAREFUSION | VELA16532-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |