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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EVACUATION CHAIR - MODEL 6254; STRETCHER, HAND-CARRIED
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STRYKER MEDICAL-KALAMAZOO EVACUATION CHAIR - MODEL 6254; STRETCHER, HAND-CARRIED Back to Search Results
Model Number 6254
Medical Device Problem Codes Difficult or Delayed Positioning (1157); Difficult to Fold, Unfold or Collapse (1254); Protective Measures Problem (3015)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
This report summarizes 1 malfunction event, where it was reported the chair was difficult to maneuver, difficult to fold, and had inadequate patient restraint.There was no patient involvement.
 
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Brand Name
EVACUATION CHAIR - MODEL 6254
Common Device Name
STRETCHER, HAND-CARRIED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11715586
Report Number0001831750-2021-00847
Device Sequence Number19813872
Product Code FPP
UDI-Device Identifier07613327261592
UDI-Public07613327261592
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number6254
Device Catalogue Number6254000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/01/2021
Initial Report FDA Received Date04/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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