MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED

Catalog Number 6252000000

Device Problem Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Pain (1994); Insufficient Information (4580)

Event Date 02/26/2023

Event Type  malfunction  

Event Description

It was reported that, while transporting a patient downstairs, the device's struts snapped, causing the chair to collapse.The patient sustained a back injury, and the emts operating the device were also injured, and out of work.Attempts are being made to gather additional injury and treatment details from the user facility.

Event Description

It was reported that, while transporting a patient downstairs, the device's struts snapped, causing the chair to collapse.The patient had some back pain, and the emts operating the device sustained minor injuries.

Manufacturer Narrative

A visual and functional inspection was performed by a stryker field service technician.It was found that the issue of the unexpected drop/collapse was due to the tracks struts being broken damaged.A stryker quality assurance engineer reached out to a contact at the user facility.He stated while transferring a heavy patient, as a result of the struts breaking on the chairs, the 2 emt's had minor bruises that required no treatment.The patient complained of back pain and was treated at the hospital.He followed up with the patient 3 days later and they no longer had back pain.This issue was resolved for the customer by inspecting the unit.A new work order will be opened if the customer would like the unit repaired.

• Brand Name: STAIR PRO - MODEL 6252
• Type of Device: STRETCHER, HAND-CARRIED
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16593527
• MDR Text Key: 311819694
• Report Number: 0001831750-2023-00317
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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