FDA Adverse Event
Other
Summary report: N
AESTIVA 3000
MDR report key: 644991
·
Received November 2, 2005
Report
- Report Number
- 644991
- Event Type
- Other
- Date Received
- November 2, 2005
- Date of Event
- October 7, 2005
- Report Date
- November 2, 2005
- Manufacturer
- DATEX-OHMEDA, INC.
- Product Code
- BSZ
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
ANESTHESIOLOGIST REPORTED THAT THERE WAS A TOTAL VALVE FAILURE ON THE ANESTHESIA MACHINE. FAILURE WAS NOTED IMMEDIATELY AND PATIENT WAS VENTILATED WITH AMBU BAG WHILE THE MACHINE WAS REPLACED. NO CHANGE NOTED IN THE PATIENT'S STATUS DURING THIS EVENT. CASE DELAYED SEVERAL MINUTES WHILE THE MACHINE WAS REPLACED. ANSTHESIOLOGIST REPORTS HAVE HAD OTHER PROBLEMS WITH MACHINE IN PREVIOUS WEEKS I.E., WHEN IN BAG MODE, CONTINUES TO VENT, BAG TO VENT SWITCH DOES NOT SWITCH COMPLETELY. EVENTS HAVE BEEN NOTED WITH SMALL, PREMATURE INFANTS. BIO-MED WAS NOTIFIED AND MANUFACTURER CAME AND CHECKED MACHINE. LEAK FOUND INTERNALLY ON EXHALATION VALVES. ALL 3 MACHINES CHECKED AND MAIN MANIFOLD SEALS/PLUNGERS/O-RINGS CHANGED ON ALL THE UNITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AESTIVA 3000 | ANESTHESIA MACHINE | BSZ | DATEX-OHMEDA, INC. | 1006-9300-000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |