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

Catalog Number 6252000000

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

It was reported that the tracks were not holding, causing the user to hurt their back when lowering the patient down the stairs.It was reported that the device tracks were spinning freely causing the user to hurt their back.It was reported that the user sought treatment a few days later for back pain and was placed on modified duty due to back pain.The device was evaluated by a field service technician and no defect was found.

• 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: 5407930
• MDR Text Key: 37682248
• Report Number: 0001831750-2016-00022
• 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
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• 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: 01/08/2016
• 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