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

Catalog Number 6252000000

Device Problem Protective Measures Problem (3015)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

It was reported that a patient slid out of the stair chair while being transported.The user facility stated that due to user error the patient's leg was not secured with ankle restraints and was dragged behind him, pulling him out of the chair.The patient was transported to the hospital for a leg injury.No further details have been provided regarding the treatment or severity of the injury.

Manufacturer Narrative

It was originally reported that the patient was transported to the hospital for a leg injury.Upon further communication with the user facility it was found that the patient's leg was not injured and did not require any treatment.Section event has been updated to reflect this.

Event Description

It was reported that a patient slid out of the stair chair while being transported.The user facility stated that due to user error the patient's leg was not secured with ankle restraints and was dragged behind him, pulling him out of the chair.It was originally reported that the patient was transported to the hospital for a leg injury; however, upon further investigation the user facility stated no injuries were found and no treatment was required.

• 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
• MDR Report Key: 10712482
• MDR Text Key: 212320987
• Report Number: 0001831750-2020-00933
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other