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