FDA Adverse Event
Death
Summary report: N
KONTRON AIR AMBULANCE TRANSPORT
MDR report key: 10812
·
Received December 13, 1993
Report
- Report Number
- 10812
- Event Type
- Death
- Date Received
- December 13, 1993
- Date of Event
- November 19, 1993
- Report Date
- December 1, 1993
- Manufacturer
- KONTRON INSTRUMENTS, INC.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT LEFT HOSP IN PRIVATE AMBULANCE TO TRANSPORT TO ANOTHER HOSP AT 10:15 PM FULLY CHARGED (14V). EN ROUTE, INFUSION PUMP WAS PLUGGED IN BUT FAILED SO MANUAL INFUSION PROCEEDED. AT 10:35 PM, THE BATTERY ON THE INTRA-AORTIC BALLOON PUMP INDICATED THERE WAS 20 MINUTES REMAINING. MINUTES LATER, THE SAME BATTERY INDICATED THERE WAS 10 MINUTES REMAINING. THE RN PLUGGED IN THE IABP INTO THE AMBULANCE'S ELECTRICAL OUTLET WHEN ALL THE POWER IN THE AMBULANCE WENT OUT. AS THE PT WAS TOTALLY DEPENDFENT ON THE BALLOON PUMP, THE PT WAS TAKEN TO ANOTHER HOSP WHERE HE DIED AFTER ACLS. THE PT WAS PRONOUNCED AT 11:23 PM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KONTRON AIR AMBULANCE TRANSPORT | INTRA-AORTIC BALLOON PUMP | DSP | KONTRON INSTRUMENTS, INC. | 9020202T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death | A.V.I. PUMP FAILED |