MAUDE Adverse Event Report: KREG MEDICAL CATALYST BARIATRIC BED; CATALYST BED

Model Number	ASM100112
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant, the patient was observed to be restless and leaning toward the left side of the bed.At the time of the incident, the patient was unattended, and both side rails were found to be in the lowered position.A post-preventive maintenance inspection was conducted to assess the bed's functionality.The bed was confirmed to be operating as intended.The incident appears to have resulted from the user not adhering to the labeling instructions and not utilizing the bed's safety features appropriately.The ifu includes instructions/cautions for the users such as: "all side rails must be in fully raised and locked positions in the below cases: bed is moved with patient.Bed is in standing position bed is in x-hale chair position.Bed is functioning.Patient is left un-attended in bed." "it is recommended that the bed exit alert always be engaged to minimize the risk of unsafe movement of patient.".
Event or Problem Description
The patient was restless and was leaning towards the left side of the bed.Both the head and foot rails were down.The nurse had left the room to find another staff member to move the patient.In that time, the patient rolled over and fell onto the floor.The patient suffered some bleeding.A ct scan was done post the fall which was negative.

• Brand Name: CATALYST BARIATRIC BED
• Common Device Name: CATALYST BED
• Manufacturer (Section D): KREG MEDICAL; 1940 janice ave; melrose park IL 60160
• Manufacturer (Section G): KREG MEDICAL; 1940 janice ave; melrose park IL 60160
• Manufacturer Contact: shweta khande ; 1940 janice ave; melrose park, IL 60160 ; 3122757017
• MDR Report Key: 22101093
• Report Number: 3005179379-2025-00011
• Device Sequence Number: 18252030
• Product Code: OSI
• UDI-Device Identifier: 00850520008020
• UDI-Public: (01)00850520008020(11)240315
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ASM100112
• Device Lot Number: 5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown