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

Catalog Number 6252000000

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that while two paramedics were operating the device with a patient, the tracks were fully locked in but failed to grip the stairs and ran away from top to the bottom of the stairs and ended up pinning the lower paramedic to the wall.The paramedic who was pinned to the wall was injured and has been taken to hospital.No details were reported on the exact injury/severity, and it was not reported if the patient was injured yet.Attempts are being made to gather additional details from the user facility.

• 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: 19006965
• MDR Text Key: 339000573
• Report Number: 0001831750-2024-00344
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

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 Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/29/2024
• 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