FDA Adverse Event Injury Summary report: N

SIEMENS - COROSKOP

MDR report key: 175649 · Received June 30, 1998

Report

Report Number
175649
Event Type
Injury
Date Received
June 30, 1998
Date of Event
April 15, 1998
Report Date
April 29, 1998
Manufacturer
SIEMENS
Product Code
IZO
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

REPORT OF INCIDENT CALLED TO COMPANY 4/15/98. SIEMENS XRAY EQUIPMENT WENT DOWN AND WOULD NOT REBOOT. PT HAD INTROCORONARY WIRE PLACED AND HAD TO BE MOVED TO ANOTHER LAB. THROMBUS DEVELOPED IN VESSEL BUT RESOLVED WITHOUT INJURY TO PT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SIEMENS - COROSKOP X RAY EQUIP. IZO SIEMENS COROSKOP *

Patients

Seq Age Sex Outcome Treatment
1 65 YR Life Threatening