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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
Catalog Number 6254000000
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2017
Event Type  malfunction  
Event Description
It was alleged that the track belt detached from the device which would cause the tracks to be unable to engage stairs during use.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental submitted to include udi.
 
Event Description
It was alleged that the track belt detached from the device which would cause the tracks to be unable to engage stairs during use.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
EVACUATION CHAIR - MODEL 6254
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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6619964
MDR Text Key77283186
Report Number0001831750-2017-00237
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeFR
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 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6254000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2016
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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