FDA Adverse Event Malfunction Summary report: N

3080 RL SURGICAL TABLE

MDR report key: 9568707 · Received January 9, 2020

Report

Report Number: 1043572-2020-00004
Event Type: Malfunction
Date Received: January 9, 2020
Date of Event: December 12, 2019
Report Date: January 9, 2020
Manufacturer: STERIS CORPORATION - MONTGOMERY
Product Code: FWW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE TABLE SUBJECT OF THE REPORTED EVENT WAS INSTALLED AT THE USER FACILITY ON MAY 14, 1993 AND IS APPROXIMATELY 26 YEARS OLD. A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE TABLE. WHILE INSPECTING THE UNIT, THE TECHNICIAN CONFIRMED THE HAND CONTROL WAS WORKING INTERMITTENTLY. THE USER FACILITY COULD NOT CONFIRM, BUT BASED ON THE TECHNICIAN'S INSPECTION, THE HAND CONTROL SUBJECT OF THE REPORTED EVENT APPEARED TO BE THE ORIGINAL HAND CONTROL, MAKING IT APPROXIMATELY 26 YEARS OLD. BASED ON THE TECHNICIAN'S INSPECTION AND THE AGE OF THE UNIT, IT WAS CONFIRMED THE CONTROL CORD HAD BECOME WORN OVER TIME, RESULTING IN THE REPORTED EVENT. THE TECHNICIAN REPLACED THE HAND CONTROL CORD, TESTED THE UNIT AND FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATIONS. THE TABLE WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THEIR 3080 RL MAJOR SURGICAL TABLE WAS INTERMITTENTLY RESPONDING TO TABLE COMMANDS VIA HAND CONTROL. THE REPORTED LOSS OF CONTROL WAS ONLY A FEW SECONDS AND DID NOT RESULT IN A DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
35976	3080 RL SURGICAL TABLE	SURGICAL TABLE	FWW	STERIS CORPORATION - MONTGOMERY

Patients

Seq	Age	Sex	Outcome	Treatment
1