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

Catalog Number 6252000000

Device Problem Detachment Of Device Component (1104)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

The stair chair was evaluated by a field service technician who reported that the device had no defect and was operating to specification.

Event Description

It was reported that a patient was injured from the stair chair flip down foot section.Further information provided by an emt who was present during the event reported that the flip down foot section of the chair came down and scrapped the patients's leg in a post surgery location of a previous injury.It was reported that the patient had late stage cancer and had very delicate skin.It was reported that when the flip down foot section of the chair came down it scrapped the patients skin to the bone.The patient required emergency surgery where they could not stop the bleeding requiring the patient to be transported to another hospital to complete the medical intervention.

• 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: 5022779
• MDR Text Key: 23801445
• Report Number: 0001831750-2015-00404
• 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
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2015
• 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