FDA Adverse Event Malfunction Summary report: N

3080 SP SURGICAL TABLE

MDR report key: 18808572 · Received February 29, 2024

Report

Report Number: 1043572-2024-00015
Event Type: Malfunction
Date Received: February 29, 2024
Date of Event: January 30, 2024
Report Date: February 29, 2024
Manufacturer: STERIS CORPORATION - MONTGOMERY
Product Code: FWW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE AND FOUND THE TABLE HAD A BROKEN FLOOR LOCK SWITCH WHICH CAUSED THE TABLE'S HAND CONTROL TO SHOW UNLOCKED, EVEN THOUGH IT WAS LOCKED. A STERIS FIELD SERVICE TECHNICIAN INSPECTED THE 3080 SP SURGICAL TABLE AND FOUND THAT ONE OF THE FLOOR LOCK SWITCHES REQUIRED REPLACEMENT. DUE TO THE FLOOR LOCK SWITCH NOT OPERATING PROPERLY, THIS CAUSED THE TABLE'S HAND CONTROL TO DISPLAY UNLOCK EVEN THOUGH IT WAS LOCKED. THE TECHNICIAN REPAIRED THE 3080 SP SURGICAL TABLE, TESTED THE TABLE, CONFIRMED IT TO BE OPERATIONAL, AND RETURNED IT TO SERVICE. THE TABLE WAS MANUFACTURED IN 1996, MAKING IT APPROXIMATELY 27 YEARS OLD. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem · 0

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE HAND CONTROL TO THEIR 3080 SP SURGICAL TABLE WOULD NOT RESPOND TO COMMANDS. USER FACILITY PERSONNEL COMMANDED THE TABLE VIA THE HAND CONTROL TO BE RAISED IN HEIGHT HOWEVER, THE HAND CONTROL INDICATED THE TABLE WAS UNLOCKED AND WOULD NOT RESPOND. USER FACILITY PERSONNEL CONFIRMED THE TABLE WAS LOCKED AND COMPLETED THE PATIENT PROCEDURE SUCCESSFULLY. NO REPORT OF INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
927823	3080 SP SURGICAL TABLE	SURGICAL TABLE	FWW	STERIS CORPORATION - MONTGOMERY

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown