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

Catalog Number 6252000000

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 07/23/2018

Event Type  malfunction  

Event Description

It was reported the stair chair did not stay in a folded position, resulting in the chair sliding down the wall and scraping a bystander's foot.There was no medical intervention or adverse consequence related to this incident.

Manufacturer Narrative

It was reported that there was no issue with the device remaining in the folded position.The event occurred as a result of the device sliding down the wall that it was leaning against.

Event Description

It was reported the stair chair slid down the wall and scraped a bystander's foot.There was no medical intervention or adverse consequence related to this incident.

• 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: 7794568
• MDR Text Key: 117831613
• Report Number: 0001831750-2018-00975
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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