MAUDE Adverse Event Report: KREG MEDICAL INC. CATALYST NON-EXPANDABLE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	ASM100113
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: CATALYST NON-EXPANDABLE BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): KREG MEDICAL INC.; 1940 janice ave.; melrose park IL 60160
• MDR Report Key: 14591565
• Report Number: 14591565
• Device Sequence Number: 5517155
• Product Code: FNL
• UDI-Device Identifier: 00850520008143
• UDI-Public: (01)00850520008143(11)200430
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/25/2022
• Report Date (Section F): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASM100113
• Device Lot Number: 4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/31/2022