FDA Adverse Event Malfunction Summary report: N

SIEMENS MEDICAL SOLUTIONS USA INC.

MDR report key: 557133 · Received October 12, 2004

Report

Report Number
MW1033608
Event Type
Malfunction
Date Received
October 12, 2004
Date of Event
September 27, 2004
Report Date
October 5, 2004
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA
Product Code
IZI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE PT WAS RECEIVED FROM ER WITH A COLD LEFT EXTREMITY, MOTTLED AND PULSELESS. THE INTENTION WAS TO PERFORM ANGIOGRAPHIC IMAGING AND POSSIBLY INTERVENTIONAL ARTERIAL WORK TO RELIEVE CONDITION AS MUCH AS POSSIBLE. DUE TO IMPAIRED RENAL FUNCTION, THE PT REQUIRED CO2 CONTRAST IMAGING TO ELIMINATE THE POSSIBILITY OF RENAL FAILURE. CO2 IMAGING IS ONLY AVAILABLE AT INSTITUTION ON THE SIEMENS AXIOM FA UNIT. RPTR WAS ABLE TO PERFORM THE ABDOMINAL AORTAOGRAM WHICH SHOWED LIMITED/NO FLOW TO THE LEFT EXTREMITY. WHEN THEY BEGAN TO SELECTIVELY VISUALIZE THE LEFT LEG THE UNIT WOULD NOT ACQUIRE A RUN. AT THAT TIME RPTR AUTO-ZEROED THE TABLE THE WAY RPTR HAD BEEN INSTRUCTED BY THE SIEMENS SERVICE PERSONNEL. THIS DID NOT CORRECT THE PROBLEM. RPTR THEN DID A SHORT BOOT (APPROX 1 MIN) AND THIS DID NOT RESOLVE THE PROBLEM. AT THIS TIME RPTR STILL HAD AN ARTERIAL CATHETER IN THE PT. SHUT DOWN THE UNIT AT THIS POINT AND RESTARTED WHICH TAKES APPROX 7 MINUTES. WHEN THE UNIT CAME BACK UP, RPTR AGAIN AUTO-ZEROED THE TABLE AND AGAIN INJECTED CO2. THE UNIT GAVE AN ERROR OF "NO XRAY". AGAIN SHUT THE UNIT DOWN WHICH AGAIN TOOK 7 MINUTES. DURING THIS TIME RPTR WAS STILL SELECTIVELY CATHETERIZED AND FLUSHING THE CATHETER TO PREVENT THE CATHETER FROM CLOTTING. WHEN THE UNIT CAME UP AGAIN, RPTR AUTO-ZEROED THE TABLE. AGAIN INJECTED THE CO2 BUT THE UNIT GAVE THE ERROR MESSAGE "NO XRAY". AT THIS POINT RPTR WAS UNABLE TO COMPLETE THE DIAGNOSTIC/INTERVENTIONAL IMAGING WORK THAT THIS PT REQUIRED AND TERMINATED THE PROCEDURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SIEMENS MEDICAL SOLUTIONS USA INC. AXIOM ARTIS FA - ANGIOGRAPHIS SYSTEM IZI SIEMENS MEDICAL SOLUTIONS USA AXIOM ARTIS FA *

Patients

Seq Age Sex Outcome Treatment
1 71 YR Other