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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 Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 11/13/2021
Event Type  Injury  
Event Description
It was reported that the stair chair broke while in use, possibly indicating a collapse.It was further reported that the patient and paramedic were injured.Attempts are being made to gather additional injury and treatment details from the user facility.
 
Manufacturer Narrative
The investigation has been completed.Section b5 has been updated with additional information and codes under section h have been updated.
 
Event Description
It was reported that during transport of a patient, the track support strut snapped causing it to collapse.As a result, the paramedics carried the chair down the stairs.The paramedic at the front of the chair slipped and the weight of the patient and chair transferred to him resulting in a back injury.There was no reported patient injury.Multiple attempts were made to the customer to obtain further information on the extent of the injuries sustained to the paramedic, but the customer was unable to be reached.
 
Manufacturer Narrative
This supplemental is being filed to correct a section h code to reflect that this was a serious injury.
 
Event Description
It was reported that during transport of a patient, the track support strut snapped causing it to collapse.As a result, the paramedics carried the chair down the stairs.The paramedic at the front of the chair slipped and the weight of the patient and chair transferred to him resulting in a back injury.There was no reported patient injury.Multiple attempts were made to the customer to obtain further information on the extent of the injuries sustained to the paramedic, but the customer was unable to be reached.
 
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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
melissa millard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key12868885
MDR Text Key281203228
Report Number0001831750-2021-01635
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/07/2022
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? Yes
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2021
Initial Date FDA Received11/24/2021
Supplement Dates Manufacturer Received11/15/2021
11/15/2021
Supplement Dates FDA Received03/03/2022
04/07/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/23/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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