FDA Adverse Event Malfunction Summary report: N

3080 SP SURGICAL TABLE

MDR report key: 12591249 · Received October 7, 2021

Report

Report Number: 1043572-2021-00071
Event Type: Malfunction
Date Received: October 7, 2021
Date of Event: September 13, 2021
Report Date: October 7, 2021
Manufacturer: STERIS CORPORATION - MONTGOMERY
Product Code: FWW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, STERIS LEARNED THAT THE HOSPITAL'S INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO USER FACILITY PERSONNEL NOT PROPERLY SECURING THE PATIENT ON THE TABLE. THE PATIENT WAS IN REVERSE TRENDELENBURG WITH A STRAP OVER THEIR THIGH AT THE TIME OF THE REPORTED EVENT. USER FACILITY PERSONNEL COMMANDED THE TABLETOP TO TILT WHEN THE PATIENT BEGAN TO SLIP OFF THE TABLE. A STERIS TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE. UNRELATED TO THE REPORTED EVENT, THE TECHNICIAN FOUND THAT THE POWER SUPPLY REQUIRED REPLACEMENT. THE TABLE WAS INSTALLED IN 1994 MAKING IT APPROXIMATELY 27 YEARS OLD AND IS NOT UNDER STERIS SERVICE AGREEMENT; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN REPLACED THE POWER SUPPLY, TESTED THE TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE PATIENT BEGAN TO SLIP OFF THEIR 3080 SP SURGICAL TABLE. THE PATIENT WAS STABILIZED AND REPOSITIONED ONTO THE SURGICAL TABLE RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1492995	3080 SP SURGICAL TABLE	SURGICAL TABLE	FWW	STERIS CORPORATION - MONTGOMERY

Patients

Seq	Age	Sex	Outcome	Treatment
1