MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS PASS-THRU

Model Number	1-2-610.003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their advantage plus pass-thru alarmed for an internal fluid leak error in the right basin.When the employee acknowledged the alarm, the left basin door opened and "sprayed" disinfectant into the room subsequently contacting an employee's eyes.The employee sought treatment at the facility's emergency room.
Additional Manufacturer Narrative
During following up with user facility personnel, it was unable to be confirmed if the employee subject of the reported event was wearing proper personal protective equipment.The operator manual states (pg.10), "wear personal protective equipment (ppe).Clothing, mask, gloves, and eye wear." a steris service technician arrived onsite following the reported event to inspect the advantage plus-pass thru.The technician inspected the unit and found that the left side basin spray arm pump was not operating properly.In addition, the technician found that a scope button was sitting in the lid channel of the left side basin.The scope button was obstructing the lid sensor which may have attributed to the left basin door opening during the time of the reported event.During the technician's inspection he was unable to find any issues with the right basin; no leaks were identified, and the reported alarm could not be duplicated.The technician replaced the spray arm pump, ran a test cycle and confirmed the unit to be operating to specifications and returned the unit to service.The advantage plus pass-thru is serviced and maintained by the user facility.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS PASS-THRU
• Common Device Name: ADVANTAGE PLUS PASS-THRU
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21025582
• Report Number: 2150060-2024-00059
• Device Sequence Number: 18234337
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: (01)00677964095832(11)210401
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 1-2-610.003
• Device Catalogue Number: 12610003
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Sex: Unknown