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

Model Number 6257

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 319041569
• Report Number: 0001831750-2023-00684
• Device Sequence Number: 1
• Product Code: ILK
• UDI-Device Identifier: 07613327581621
• UDI-Public: 07613327581621
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K222818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1