FDA Adverse Event
Malfunction
Summary report: N
IMPACT INSTRUMENTATION, INC.
MDR report key: 556258
·
Received November 19, 2004
Report
- Report Number
- 556258
- Event Type
- Malfunction
- Date Received
- November 19, 2004
- Date of Event
- November 12, 2004
- Report Date
- November 15, 2004
- Manufacturer
- IMPACT INSTRUMENTATION
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA, US
- Reporter Occupation
- PARAMEDIC
Narratives
Description of Event or Problem · 1
PT WAS BEING TRANSFERRED FROM HOSPITAL TO HOSPITAL. PT WAS PUT ON VENT AND DURING TRANSFER THE VENT ALARMED PROBLEM WITH O2. O2 WAS CHECKED AND ALSO SWITCHED OVER TO MAIN O2 SUPPLY. IT ALARMED ON MAIN O2 SUPPLY ABOUT 35 TO 45 SEC. WITH NO IMPROVEMENT. VENT WAS ALSO CHARGED AND PLUGGED INTO THE AC OUTLET WHEN PROBLEM OCCURRED. PT HAD NO COMPROMISE DUE TO MEDIC BAGGING THE REST OF THE TRANSFER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPACT INSTRUMENTATION, INC. | EAGLE VENT | CBK | IMPACT INSTRUMENTATION | EAGLE VENT 754 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |