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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 Problems Collapse (1099); Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 01/27/2014
Event Type  malfunction  
Event Description
It was alleged that upon descending a flight of stairs with a patient that the tracks had collapsed in the middle of the stairs after successfully descending one flight of stairs.The user at the foot end received a back injury that did not require medical intervention.The patient and the head end user did not receive injuries from the event and the procedure was completed successfully.The field technician reported that they were unable to duplicate the alleged event and did not find any defects on the device.It was further reported by the field technician that the customer said the user had pulled the wrong release lever attempting to engage the tracks in between flights of stairs.No patient was affected and no adverse consequence or clinically relevant delay in treatment 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
anthony noora
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3654027
MDR Text Key4320479
Report Number0001831750-2014-01892
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/07/2014
Was Device Evaluated by Manufacturer? Yes
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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