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

Catalog Number	625705550002
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated as the cause was determined by analyzing data provided by the user/third party; no further assistance was requested by the customer.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the devices experienced inadequate patient restraint.There was no patient involvement.
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the devices experienced inadequate patient restraint.There was no patient involvement.
Additional Manufacturer Narrative
1 pending device was not evaluated but reviewed by data and confirmed the issue.Section h codes have been updated.

• 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: 20558729
• Report Number: 0001831750-2024-01337
• Device Sequence Number: 11575826
• Product Code: ILK
• UDI-Device Identifier: 07613327581607
• UDI-Public: 07613327581607
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222818
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 03/31/2025
• 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