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

Catalog Number 6252000000

Device Problem Component Missing (2306)

Patient Problem Injury (2348)

Event Date 07/23/2018

Event Type  malfunction  

Event Description

It was reported that the emt's were were transporting a large patient which required the chair's straps to be fully extended.The patient's weight shifted to one side causing the end of the strap to slide through the buckle clip (inadequate patient restraint) leading to a rapid shift of patient weight.This weight shift lead to a reported back injury of one of the members of the crew who required occupational therapy as a result.There were no adverse consequences to the patient.

Manufacturer Narrative

No defects or malfunctions were reported with the unit by the user facility.It was stated that the unit did not tip, but that the user who was operating the stair-pro injured their back as the result of attempting to stabilize the patient.It was stated that the user went to the occupational therapist for documentation purposes and did not require further medical attention or time off of work.No device problem occurred.

Event Description

It was reported that the emt's were transporting a large patient which required the chair's straps to be fully extended.The patient's weight shifted to one side causing the end of the strap to slide through the buckle clip leading to a rapid shift of patient weight.This weight shift lead to a reported back injury of one of the members of the crew who required occupational therapy as a result.There were no adverse consequences to the patient.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7786020
• MDR Text Key: 117437296
• Report Number: 0001831750-2018-00971
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2008
• 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