FDA Adverse Event
Other
Summary report: N
PULMONARY FUNCTION MACHINE
MDR report key: 11805
·
Received March 1, 1994
Report
- Report Number
- MW1000930
- Event Type
- Other
- Date Received
- March 1, 1994
- Date of Event
- February 14, 1994
- Report Date
- February 14, 1994
- Manufacturer
- CYBERMEDIC, INC.
- Product Code
- BTY
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
PULMONARY FUNCTION MACHINE HAD STRONG BURNING ODOR COMING FROM UNIT. PT WAS REMOVED FROM AREA. MACHINE WAS SHUT OFF AND UNPLUGGED AND WILL REMAIN SO UNTIL REPAIRS ARE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONARY FUNCTION MACHINE | BTY | CYBERMEDIC, INC. | CM 310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other |