MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6257 XPEDITION HIGH CONFIG; TRANSPORT, PATIENT, POWERED

Catalog Number	625705550002
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the devices experienced stair tread/tracks descends/ascends too fast.There was 1 event with patient involvement: the patient experienced unknown.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
The 4 pending devices were not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; no defect or malfunction was found.Section h codes have been updated.
Event or Problem Description
There was 1 event with patient involvement.It was originally unknown, but more information was received and the patient sustained a bruise and experienced pain.

• Brand Name: 6257 XPEDITION HIGH CONFIG
• Common Device Name: TRANSPORT, PATIENT, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 21920132
• Report Number: 0001831750-2025-00585
• Device Sequence Number: 9086410
• Product Code: ILK
• UDI-Device Identifier: 07613327581607
• UDI-Public: 07613327581607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222818
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 625705550002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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