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

Catalog Number 6252000000

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

This report summarizes 61 malfunction events, where it was reported the devices experienced difficulty maneuvering.There was 1 event with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.53 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices were functionally/visually inspected in the field; no defects or malfunctions were found.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.1 device was functionally/visually inspected in the field; no defect or malfunction was found.4 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

2 of the investigations were completed via analysis of data provided by the user, but the issue was not confirmed; no defect or malfunction was found.2 of the final devices were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.

Event Description

This report summarizes 61 malfunction events, where it was reported the devices experienced difficulty maneuvering.There was 1 event with patient involvement.No adverse consequences were reported.

• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13306845
• MDR Text Key: 287900679
• Report Number: 0001831750-2022-00220
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 61
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2022
• Was Device Evaluated by Manufacturer?: No
• 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