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

Catalog Number 6252000000

Device Problem Device Tipped Over (2589)

Patient Problem Pain (1994)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that while transporting a patient one of the paramedics slipped, causing the stair chair to tip.As a result, the patient hit their head and complained of head and shoulder pain.One of the paramedics complained of back pain.Attempts are being made to gather treatment/severity details for the reported injuries.

Event Description

It was reported that while transporting a patient one of the paramedics slipped, causing the stair chair to tip.As a result, the patient hit their head and complained of head and shoulder pain.One of the paramedics complained of back pain.The user facility stated that no treatment was required for the paramedic or patient.

Manufacturer Narrative

The user facility followed up and confirmed that no treatment was needed.Section h codes have been updated.

• 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: kelsey barla ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13045554
• MDR Text Key: 282517562
• Report Number: 0001831750-2021-01654
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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