FDA Adverse Event Malfunction Summary report: N

CATALYST NON-EXPANDABLE BED

MDR report key: 14591565 · Received June 3, 2022

Report

Report Number
14591565
Event Type
Malfunction
Date Received
June 3, 2022
Date of Event
April 21, 2022
Report Date
May 25, 2022
Manufacturer
KREG MEDICAL INC.
Product Code
FNL
UDI-DI
00850520008143
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MD
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

AT APPROXIMATELY 0730, EMPLOYEE 1 AND EMPLOYEE 2 WERE TRANSPORTING A PATIENT FROM THE ICU TO THE DIALYSIS UNIT. ALONG THE ROUTE FROM THE ICU TO THE DIALYSIS UNIT, THE EMPLOYEES ENCOUNTERED CONSTRUCTION BARRIER THAT NARROWED THE PASSAGEWAY OF THE HALLWAY. AS THEY WERE CROSSING THE NARROWED PASSAGEWAY, EMPLOYEE 1'S RIGHT HAND WAS CAUGHT BETWEEN A "STOP THE BLEED" KIT MOUNTED ON THE WALL OF THE HALLWAY AND THE BED'S FOOT BOARD. EMPLOYEE 1'S RIGHT FINGERTIP WAS AVULSED IN THE INCIDENT. THE CATALYST BED FOOTBOARD HAS HAND HOLES AT THE 3 AND 9 O'CLOCK POSITIONS AND EMPLOYEE 1 HAD HER HANDS IN THE BED'S HAND HOLES AT THE TIME OF THE INCIDENT. EMPLOYEE 1 WAS POSITIONED WITH HER BACK TOWARD THE DIRECTION OF TRAVEL. EMPLOYEE 2 SHOUTED A WARNING, BUT THIS WAS TOO LATE TO ALLOW TIME FOR EMPLOYEE 1 TO REACT TO STEER OR BRAKE THE BED. EMPLOYEE 1 WAS AT THE HEAD OF THE BED, ALSO PUSHING AN IV POLE. THE BED AND PATIENT WEIGHED APPROXIMATELY 575 KG. BOTH EMPLOYEES NOTED THAT THE BED TRACKED IN A STRAIGHT LINE WITHOUT ISSUE BUT WAS DIFFICULT TO STEER OR TURN. AT THE TIME OF THE INCIDENT, THE BED WAS TRAVELING IN A STRAIGHT LINE. THE MASS OF THE BED AND PATIENT (MOMENTUM) AND THE EMPLOYEE'S BACK POSITIONED TOWARD THE DIRECTION OF TRAVEL LIKELY CONTRIBUTED TO THE INABILITY TO STEER CLEAR OF THE PINCH POINT. THE POSITION OF THE HAND HOLES IN THE BED'S FOOT BOARD CONTRIBUTED ALSO BY POSITIONING THE EMPLOYEE'S HANDS IN A VULNERABLE POSITION. THE RIGID NATURE OF THE FOOTBOARD MOUNTING WAS UNFORGIVING WHEN IN CONTACT WITH ANOTHER OBJECT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1832848 CATALYST NON-EXPANDABLE BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL KREG MEDICAL INC. ASM100113 4 00850520008143

Patients

Seq Age Sex Outcome Treatment
1 Unknown Other