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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6251; STRETCHER, HAND-CARRIED
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STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6251; STRETCHER, HAND-CARRIED Back to Search Results
Catalog Number 6251000000
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2020
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.This device was repaired and returned to use.1 device was not made available for inspection by the end user.1 device is pending investigation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 4 malfunction events, where it was reported the unit was difficult to maneuver (no tip). there was no patient involvement.
 
Event Description
This report summarizes 4 malfunction events, where it was reported the unit was difficult to maneuver (no tip).  there was no patient involvement.
 
Manufacturer Narrative
The final device was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.
 
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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
MDR Report Key11239697
MDR Text Key229132019
Report Number0001831750-2021-00337
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Number of Events Reported4
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6251000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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