FDA Adverse Event
Injury
Summary report: N
IMPACT INSTRUMENTATION, INC
MDR report key: 346427
·
Received August 9, 2001
Report
- Report Number
- 346427
- Event Type
- Injury
- Date Received
- August 9, 2001
- Date of Event
- July 25, 2001
- Report Date
- August 8, 2001
- Manufacturer
- IMPACT INSTRUMENTATION, INC
- 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 BEING TRANSPORTED ON PORTABLE VENTILATOR. LOW BATTERY INDICATOR CAME ON, VENTILATOR WAS PLUGGED INTO AC POWER SOURCE WITH ACCOMPANYING CHARGER. CHARGER FAILED TO POWER VENTILATOR, AND VENTILATOR SHUT OFF. ALTERNATE EQUIPMENT AVAILABLE AND IMMEDIATELY IMPLEMENTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36032 | IMPACT INSTRUMENTATION, INC | UNIVERSAL AC POWER SUPPLY | CBK | IMPACT INSTRUMENTATION, INC | 754 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Life Threatening |