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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EVACUATION CHAIR 6253 - OBS; STRETCHER, HAND-CARRIED
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STRYKER MEDICAL-KALAMAZOO EVACUATION CHAIR 6253 - OBS; STRETCHER, HAND-CARRIED Back to Search Results
Catalog Number 6253000000
Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)
Patient Problems Bruise/Contusion (1754); Injury (2348)
Event Date 05/02/2018
Event Type  malfunction  
Event Description
It was reported that the stair chair was on the last two steps when the track came loose and the wheel of the chair hit the last step.The occupant of the chair fell forward and hit her knees and head.She had bruising but did not have a concussion.She received x-rays confirming that nothing was broken.Ice was applied to the injured areas and no medications were administered.
 
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Brand Name
EVACUATION CHAIR 6253 - OBS
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7550729
MDR Text Key109625347
Report Number0001831750-2018-00505
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6253000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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