FDA Adverse Event
Malfunction
Summary report: N
AISYS
MDR report key: 3329473
·
Received August 30, 2013
Report
- Report Number
- 3329473
- Event Type
- Malfunction
- Date Received
- August 30, 2013
- Date of Event
- August 27, 2013
- Report Date
- August 30, 2013
- Manufacturer
- GE HEALTHCARE, LLC
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS BEING INDUCED UNDER ANESTHESIA WHEN THE CRNA AND MDA WENT TO VENTILATE THE PATIENT THEY WERE UNABLE TO SO BECAUSE THERE WAS AN AIR LEAK. THE VALVE ON THE CONDENSATION TRAP APPEARS TO HAVE STUCK OPEN THUS ALLOWING AIR TO ESCAPE; PREVENTING PROPER VENTILATION. STAFF REVIEWED THE NORMAL PROCESS AND ALGORITHM AND FOUND NO PRACTICE DEVIATIONS FROM THE STANDARD WORK. AS A RESULT OF THIS INCIDENT THEY HAD TO WAKE THE PATIENT, CHANGED ROOMS AND EQUIPMENT AND RE-INDUCED THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431006 | AISYS | GAS-MACHINE, ANESTHESIA | BSZ | GE HEALTHCARE, LLC | AISYS | N/A | |
| 431007 | * | --- | |||||
| 431008 | * | --- |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES |