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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 Insufficient Information (3190)
Patient Problems Fall (1848); Laceration(s) (1946); Injury (2348)
Event Date 06/21/2017
Event Type  malfunction  
Manufacturer Narrative
The stair chair was immediately taken out of service as a precaution and checked by a third party service provider.No defect with the stair chair could be identified and the stair chair was returned to use by the user facility.The device was evaluated by a 3rd party service provider.
 
Event Description
It was reported that two emts were transporting a patient down some stairs when both emts fell.One received a minor cut, applied a band-aid, no medical intervention and was not seen by a doctor.The second emt received a rotator cuff injury and was seen by emergency room, received x-rays, and followed up with his employee health.The injured emt remains out of work.No injury to the patient was 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
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 Key6727432
MDR Text Key80659026
Report Number0001831750-2017-00305
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 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/21/2017
Initial Date FDA Received07/20/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/20/2010
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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