FDA Adverse Event Malfunction Summary report: N

HUT EXT DR FINAL ASSY-REVERSE

MDR report key: 3973044 · Received April 29, 2014

Report

Report Number: 1518293-2014-00051
Event Type: Malfunction
Date Received: April 29, 2014
Date of Event: April 11, 2014
Report Date: April 11, 2014
Manufacturer: LIEBEL-FLARSHEIM
Product Code: IXR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MALLINCKRODT TECH SUPPORT (TS) TROUBLESHOT WITH CUSTOMER WHO REPORTED THAT WHEN THEY PRESSED THE FLUORO/RAD PEDALS, NOTHING HAPPENS, NO ERRORS, ONLY A MESSAGE ON THE TABLE DISPLAY THAT STATES PREPARING TO EXPOSE. THEN WHEN THEY LET OFF THE PEDALS, IT STATES EXPOSURE CANCELLED PEDAL RELEASED. TECH SUPPORT FOUND THE CUSTOMER DIDN'T HAVE A PT FILE OPEN AND EXPLAINED THE INFIMED I5 REQUIRES A PT FILE TO BE OPENED IN ORDER TO FLUORO OR PERFORM A DIGITAL SPOT EXPOSURE. CUSTOMER OPENED A TEST PT FILE AND THE SYSTEM ALLOWED FLUORO/DIGITAL SPOTS. SYSTEM IS FULLY FUNCTIONAL, THIS WAS OPERATOR ERROR.

Description of Event or Problem · 1

CUSTOMER REPORTS THAT INCIDENT OF NO FLUORO OCCURRED WHEN A PT WAS ON THE TABLE, HOWEVER, THE STAFF WAS STILL ABLE TO COMPLETE THE PROCEDURE USING THE TABLE WITHOUT INCIDENT. NO PT OR PROCEDURAL INFO MADE AVAILABLE. NO PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
255538	HUT EXT DR FINAL ASSY-REVERSE		IXR	LIEBEL-FLARSHEIM	HUT EXT DR FINAL A	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK