FDA Adverse Event
Malfunction
Summary report: N
NARKOMED NAD
MDR report key: 404499
·
Received July 9, 2002
Report
- Report Number
- MW1025533
- Event Type
- Malfunction
- Date Received
- July 9, 2002
- Date of Event
- December 13, 2001
- Report Date
- July 9, 2002
- Manufacturer
- NARKOMED NAD
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AFTER ROUTINE INDUCTION OF ANESTHESIA USING 10LPM O2, A CHANGE IN O2 FLOWMETER OCCURS. UNABLE TO MANIPULATE FLOWMETER, FORCING ANESTHESIA TEAM TO RESORT TO AMBU VENTILATION OF PT FOR ABOUT 5 MINS WHILE AN EXCHANGE OF ANESTHESIA MACHINES CAN BE DONE. 1ST MACHINE TAKEN OUT OF SVC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NARKOMED NAD | 10LPM O2 | BSZ | NARKOMED NAD | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |