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

Model Number	6257
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device got stuck on the way up a slightly winding staircase.There was no patient involvement, and no adverse consequence or clinically relevant delay in treatment was reported.Attempts are being made to gather additional details from the user facility.
Event or Problem Description
It was reported that the device got stuck on the way up a slightly winding staircase.There was no patient involvement, and no adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
After investigation, it was determined that the issue occurred during a demonstration of the chair.The user was too close to the railing on a winding staircase, and the tracks caught part of the railing.A visual and functional inspection was performed by a stryker field service technician.It was found that the difficult to maneuver chair was due to user error, resulting in a bent track rail guide cage.This issue was resolved for the customer by replacing the track guide.

• Brand Name: 6257 XPEDITION POWERED CHAIR
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17325309
• Report Number: 0001831750-2023-00684
• Device Sequence Number: 12146754
• Product Code: ILK
• UDI-Device Identifier: 07613327581621
• UDI-Public: 07613327581621
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K222818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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 Model Number: 6257
• Device Catalogue Number: 625700000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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