FDA Adverse Event
Malfunction
Summary report: N
AISYS 9R ANESTHESIA MACHINE
MDR report key: 1953724
·
Received January 7, 2011
Report
- Report Number
- MW5018901
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 7, 2011
- Manufacturer
- GE HEALTHCARE
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
HUSBAND WITH AN ANESTHESIOLOGIST AT COUNTY HOSP IN (B)(6), PLACED A CALL TO NOTIFY WIFE OF ANESTHESIA MACHINES FAILING. KEEP TURNING THEMSELVES OFF. NO PT INVOLVED. MACHINE IS PART OF A RECALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AISYS 9R ANESTHESIA MACHINE | ANESTHESIA MACHINE | BSZ | GE HEALTHCARE | AISYS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |