FDA Adverse Event Malfunction Summary report: N

HUT EXT DR FINAL ASSY-STANDARD

MDR report key: 3871283 · Received April 15, 2014

Report

Report Number: 1518293-2014-00043
Event Type: Malfunction
Date Received: April 15, 2014
Date of Event: March 17, 2014
Report Date: March 17, 2014
Manufacturer: LIEBEL-FLARSHEIM
Product Code: IXR
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER CALLED TECH SUPPORT REPORTING THEY WERE NOT ABLE TO FLUORO OR TAKE RAD SHOTS AND WERE DECIDING IF THEY NEEDED TO HAVE A SERVICE ENGINEER VISIT THE SITE. CUSTOMER SAID THEY NEEDED TO SEE IF THEIR OWN BIOMED COULD FIX THE UNIT, AND WOULD CALL BACK IF NEEDED. ON A TECH SUPPORT FOLLOW UP CALL, CUSTOMER SAID THAT THE FSE (FIELD SERVICE ENGINEER) WAS NO LONGER ENDED FOR THIS UNIT. THEY DETERMINED THE PROBLEM WAS WITH THE MONITOR POWER SUPPLY AND HAD ORDERED A PART FROM LIEBEL FLARSHEIM TECH SUPPORT THEN CLOSED THE SERVICE TICKET. HOWEVER, THE CUSTOMER CALLED BACK (B)(4) SAYING THEY NOW WANTED THE FSE TO REPLACE THE POWER SUPPLY. FSE REPLACED THE POWER SUPPLY, BUT AFTER SAME TISSUE RE-OCCURRED, RE-INSTALLED THE CUSTOMERS ORIGINAL POWER SUPPLY. THE FSE FURTHER EVALUATED AND FOUND THE INTERMITTENT PROBLEM TO BE THE INFIRMED COMPUTER AND REPLACED THE CUSTOMERS COMPUTER WITH A LOANER. UNIT WAS CHECKED FOR PROPER OPERATION AND RETURNED TO THE CUSTOMER FOR SERVICE.

Description of Event or Problem · 1

CUSTOMER REPORTS VIA PHONE THAT FLUORO FAILED DURING A PT PROCEDURE, STAFF BROUGHT A PORTABLE C-ARM FLUORO UNIT IN TO COMPLETE THE PROCEDURE. NO REPORTED INJURY. CUSTOMER PROVIDED NO FURTHER INFO ABOUT THE PT OR PROCEDURE, OTHER THEN TO SAY THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
230641	HUT EXT DR FINAL ASSY-STANDARD		IXR	LIEBEL-FLARSHEIM	HUT EXT DR FINAL A	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK