FDA Adverse Event Malfunction Summary report: N

SOMATOM SENSATION 64

MDR report key: 8296726 · Received February 1, 2019

Report

Report Number: 8296726
Event Type: Malfunction
Date Received: February 1, 2019
Date of Event: January 10, 2019
Report Date: January 16, 2019
Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
Product Code: JAK
Product Problem: Yes
Report Source: User Facility report
Reporter Location: ME
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

HAD A PATIENT ON THE TABLE FOR A CT SCAN OF HER CHEST. WHILE PERFORMING THE TOPOGRAM THE TABLE MADE ONE CLICK TO MOVE AND THEN STOPPED. THE IMAGE WAS ATTEMPTED TO BE REPEATED AND THE SAME ERROR OCCURRED. THE PATIENT WAS MOVED FROM ONE CT INTO ANOTHER WHERE WE COULD COMPLETE THE EXAM. THE MACHINE WAS WORKING FINE ALL DAY UNTIL THIS ERROR. WHILE I WAS NOT AROUND IT IS MY UNDERSTANDING THAT THE SAME ERROR OCCURRED YESTERDAY AROUND THE SAME TIME AND SERVICE CAME IN TO LOOK AT THE MACHINE BUT COULD NOT DUPLICATE THE ERROR BUT COULD SEE IT IN THE LOG. WE WERE TOLD IT WAS OK THE USE THE MACHINE AND A NEW PART WAS ORDERED WITH PLANS OF REPLACING IT. SIEMENS WILL BE CONTACTED THAT THE SAME ERROR OCCURRED AND TO COME IN ABOUT FIXING IT. MANUFACTURER RESPONSE FOR CT SCANNER, SOMATOM SENSATION 64/CARDIAC 64 (PER SITE REPORTER). ACCORDING TO THE SIEMENS TECHNICIAN'S FIELD REPORTS THE FOC (OR FIELD-ORIENTATED CONTROL) BOARD WAS THE PART THAT HAD STOPPED WORKING AND ONCE IT WAS REPLACED WITH THE SPECIFIC D514/FOC BOARD, THE MACHINE BEGAN FUNCTIONING AS NORMAL AGAIN. IT IS UNCLEAR IN ALL FIELD REPORTS SUBMITTED BY SIEMENS AS TO WHAT COULD POSSIBLY CAUSE THIS MALFUNCTION. THIS INCIDENT CAUSED SEVERAL INSTANCES OF PATIENT CARE DELAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
90701	SOMATOM SENSATION 64	SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED	JAK	SIEMENS MEDICAL SOLUTIONS USA, INC.	SOMATOM SENSATION 64/CARDIAC 64

Patients

Seq	Age	Sex	Outcome	Treatment
1	22265 DA