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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 Tipped Over (2589)
Patient Problem Spinal Column Injury (2081)
Event Date 07/22/2020
Event Type  Injury  
Event Description
It was reported that during transport of a (b)(6) patient the stair chair handle allegedly broke, likely resulting in the device tipping over.As a result of the event, one paramedic was injured.The paramedic was diagnosed with cervico-lumbar sprain and had to stop working; the facility reported the paramedic will likely require physiotherapy treatments.
 
Event Description
It was reported that during transport of a 400lb patient the stair chair handle allegedly broke, likely resulting in the device tipping over.As a result of the event, one paramedic was injured.The paramedic was diagnosed with cervico-lumbar sprain and had to stop working; the facility reported the paramedic will likely require physiotherapy treatments.
 
Manufacturer Narrative
After investigation, the cause for the alleged tip resulting in an injury to a caregiver was a broken/damaged handle.The labeling review identified that the unit had exceeded its service life which could have contributed to the alleged issue.Device not made available by customer.
 
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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
MDR Report Key10422405
MDR Text Key203525103
Report Number0001831750-2020-00882
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6252000000
Was Device Available for Evaluation? No
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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