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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 Break (1069); Connection Problem (2900)
Patient Problem Injury (2348)
Event Date 11/29/2016
Event Type  malfunction  
Event Description
It was alleged that the track belts were damaged and would not engage allegedly causing the user to strain their back.
 
Manufacturer Narrative
The user received a minor strain which did not require medical treatment.
 
Event Description
It was alleged that the track belts were damaged and would not engage allegedly causing the user to strain their back.
 
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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 Key6197810
MDR Text Key63486674
Report Number0001831750-2016-00414
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,Followup
Report Date 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
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
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2010
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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