MAUDE Adverse Event Report: KREG MEDICAL, INC CATALYST NON-EXPANDABLE BED

Model Number	ASM100113
Medical Device Problem Codes	Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Crushing Injury (1797); Deformity/ Disfigurement (2360)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 at approximately 5:00 pm, it was reported directly to kreg sales representative via a phone call from the facility nurse manager that an incident had occurred with one of the kreg beds.The nurse manager provided a basic initial verbal statement of the incident.She reported that a nurse technician had a finger amputated after an incident related to her involvement in transporting a patient on a kreg bed to dialysis.The initial report stated the patient care technician was pulling the bed and a nurse was pushing the bed when it hit a box attached to the wall, no further details were provided at the time.
Additional Manufacturer Narrative
On (b)(6) 2022 at approximately 5:20 pm, kreg's sales representative contacted the facility's director of safety, and he provided additional details.An rn and patient technician were transporting a patient to dialysis 3rd floor, north building.The patient technician was pulling the bed with her hands on the footboard.The rn was pushing the bed and an iv pole stand when the incident occurred.On (b)(6) 2022 kreg's sales representative inspected the bed after patient use on-site before removing it from the facility and found the bed functions to be working as intended along with the bed reference guide attached to the bed.He inspected the bed steering and brake functions of the bed and took pictures and videos to confirm their functionality.Later that day on (b)(6) 2022, the facility eqd manager had the facility's bed repair team evaluate the kreg bed.The facility bed repair team determined and communicated to the kreg's sales representative that the bed functions were without any issues.Steer, neutral, and the brakes were demonstrated among other functions to be working as intended.On (b)(6) 2022 at 11:16 am, the bed was removed from the facility and brought back to the distribution center for processing, the bed was evaluated by kreg maintenance technician an 80-point inspection was conducted on the product with no electrical or mechanical findings.Record# (b)(4).On (b)(6) 2022 at 11:30 am, kreg's sales representative along with kreg's director of sales visited the scene and found that it was under construction at the time of the event and that the hallway width had been narrowed by a provisional wall that protruded into the hallway.As of the date of this document, the facility has not yet released its internal report of this incident to kreg.If kreg receives further information a supplemental report will be submitted.

• Brand Name: CATALYST NON-EXPANDABLE BED
• Common Device Name: CATALYST NON-EXPANDABLE BED
• Manufacturer (Section D): KREG MEDICAL, INC; 1940 janice ave; melrose park IL 60160 1009
• Manufacturer Contact: craig poulos ; 1940 janice ave; melrose park, IL 60160-1009 ; 3128298904
• MDR Report Key: 14326510
• Report Number: 3005179379-2022-00005
• Device Sequence Number: 14780538
• Product Code: FNL
• UDI-Device Identifier: 00850520008143
• UDI-Public: (01)00850520008143(11)200430
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: ASM100113
• Device Lot Number: 4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female