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

Catalog Number 625705550002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 12/10/2023

Event Type  Injury  

Event Description

It was reported that the device was used to go down the front stairs of a single family residence while it was raining.When the device hit the second step, it started to slip and lost traction, sliding to the third step.The loss of traction caused the weight of the device to tweak the provider's back and pulled him down.Later, the provider complained that his back really hurt.

• Brand Name: 6257 XPEDITION HIGH CONFIG
• 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: 18504959
• MDR Text Key: 332797456
• Report Number: 0001831750-2024-00011
• Device Sequence Number: 1
• Product Code: ILK
• UDI-Device Identifier: 07613327581607
• UDI-Public: 07613327581607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 625705550002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other