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

Model Number	ASM100113
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No hardware, firmware, or electrical malfunctions were identified.The bed-exit alarm was functional earlier in the day but not re-armed following a prior alarm condition.Side rail position and nurse-call not engaged contributed to the patient's ability to exit the bed without immediate detection.All other device subsystems met specifications during inspection.The event was determined to be primarily use-related, associated with procedural setup and re-arming practices.
Event or Problem Description
At approximately 18:30 on (b)(6) 2025, a patient slid out of the right side of a catalyst® non-bariatric bed while unattended.The right head rail was partially down, the nurse call cable was unplugged, and the bed-exit alarm, though reported as on did not sound until after the patient was repositioned.The patient sustained a head injury that required ct imaging, which revealed a small brain bleed.The patient remained stable and did not require icu transfer.

• Brand Name: CATALYST BED
• 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 ; 3128298904
• MDR Report Key: 24326959
• Report Number: 3005179379-2025-00014
• Device Sequence Number: 9674319
• Product Code: FNL
• UDI-Device Identifier: 00850520008143
• UDI-Public: (01)00850520008143(11)220429
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: ASM100113
• Device Lot Number: 7
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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 Sex: Male
• Patient Weight: 77 KG