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

Catalog Number 6252000000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

The ambulance crew positioned the tracks in preparation for the descent on the top step of the staircase.The customer reported that once the chair started moving, the tracks did not work as they were supposed to, which resulted in a rapid acceleration of the chair and patient down a few steps.The ambulance crew member who was holding onto the top chair handle took the full weight of the chair and patient but managed to stop the descent.The patient was not injured during this event.The operator who took the weight of the chair and patient reported that he developed lower right lumbar discomfort and right shoulder discomfort in the days following the event and self-medicated with anti-inflammatories.The customer reported this event as a minor injury event.

• 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: 4414003
• MDR Text Key: 5378808
• Report Number: 0001831750-2015-00012
• 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: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2014
• 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