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

Model Number	ASM100113
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After conducting a thorough investigation of the data log and testing the suspected device, it was found that the device was functioning as intended.No error codes were observed.The pre & post preventive maintenance records indicate that the device was functioning as intended.The side rails and bed exit alarm were functional.Overall, the device showed no errors.
Event or Problem Description
On (b)(6) 2026, at approximately 9:30 am, a patient was found on the floor beside the catalyst® bed at evanston hospital.The patient sustained a mandibular fracture because of the fall.At the time of the discovery, the bed exit alarm indicator light was off, and no audible alarm had been reported by nursing staff.

• Brand Name: CATALYST
• Common Device Name: CATALYST NON-BARIATRIC 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 ; 8667605734
• MDR Report Key: 24915571
• Report Number: 3005179379-2026-00015
• Device Sequence Number: 13211485
• Product Code: FNL
• UDI-Device Identifier: 00850520008143
• UDI-Public: (01)00850520008143(11)210202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: ASM100113
• Device Lot Number: 5
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Male