MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6251; STRETCHER, HAND-CARRIED

Catalog Number 6251000000

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device was difficult to maneuver but did not tip over.There was no patient involvement.

• Brand Name: STAIR PRO - MODEL 6251
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15659061
• MDR Text Key: 304804753
• Report Number: 0001831750-2022-00966
• 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): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6251000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2022
• 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