Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED Back to Search Results
Catalog Number 6252000000
Device Problems Difficult or Delayed Positioning (1157); Device Fell (4014)
Patient Problems Abrasion (1689); Bruise/Contusion (1754); Pain (1994); Insufficient Information (4580)
Event Date 08/07/2022
Event Type  Injury  
Event Description
It was reported that a crew were using the stair-pro on a set of stairs and the tracks lost traction to the stairs and the stair-pro ¿fell away¿ from the operators.One of the operators sustained an injury on their back as a result of this incident and has been off work since this happened.No patient injury was reported.Further information has not been reported.
 
Manufacturer Narrative
A second injury was reported during the process of investigation, event details have been updated in section b5.The treatment of the injured caregivers has also been provided.The first caregiver was sent to the emergency department after the incident and was referred to physio and occupational therapy.The second caregiver involved in the incident was taking ibuprofen for the pain.
 
Event Description
It was reported that a crew were using the stair-pro on a set of stairs and the tracks lost traction to the stairs and the stair-pro ¿fell away¿ from the operators.It was further reported that one operator sustained a back injury causing pain in addition to a bruised rib and an abrasion on the arm.It was additionally reported that another caregiver bumped their head, bruised their back, and had back pain in order to stop the chair from falling.No patient was injured due to this incident.
 
Manufacturer Narrative
As a result of this event, a visual and functional inspection was performed by a field service technician.It was identified that the the device had no component level defect that would have contributed to the event.The event that occurred was likely due to user error of the product, however this could not be confirmed.It was additionally stated that the customer was retrained on product use and it was also suggested that the track rollers be replaced out of abundance of caution following the incident.
 
Event Description
It was reported that a crew were using the stair-pro on a set of stairs and the tracks lost traction to the stairs and the stair-pro ¿fell away¿ from the operators.It was further reported that one operator sustained a back injury causing pain in addition to a bruised rib and an abrasion on the arm.It was additionally reported that another caregiver bumped their head, bruised their back, and had back pain in order to stop the chair from falling.No patient was injured due to this incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15311820
MDR Text Key298797582
Report Number0001831750-2022-00906
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
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? No
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2018
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;
-
-