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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED Back to Search Results
Catalog Number 6252000000
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.47 devices were evaluated in the field and the issue was confirmed; 30 devices had broken/damaged components, 9 devices had worn components, 5 devices had missing components, 1 device had a detached component, 1 device had a dirty component, 1 device had a bent component, 2 devices were peeling, and 1 device had an alignment issue.The devices were repaired and returned.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 49 malfunction events, where it was reported the device was difficult to maneuver.There were 2 instances with patient involvement; no adverse consequences were reported.
 
Manufacturer Narrative
The final device was not made available for evaluation by the customer; therefore, the cause of the reported issue could not be confirmed.
 
Event Description
This report summarizes 49 malfunction events, where it was reported the device was difficult to maneuver.There were 2 instances with patient involvement; no adverse consequences were reported.
 
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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
MDR Report Key10733743
MDR Text Key213005171
Report Number0001831750-2020-00944
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Number of Events Reported49
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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