• 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 Unintended System Motion (1430); Device Slipped (1584)
Patient Problem Injury (2348)
Event Date 02/16/2015
Event Type  Injury  
Event Description
The customer reported that while transporting a patient down the stairs the tracks allegedly seemed loose and the stair pro felt like there was allegedly a sudden increase in motion of the chair.The customer reported that the paramedic holding the chair had to take the complete weight of the patient and has allegedly reported a knee, back, and shoulder injury requiring anti inflammatory medication.No injury to the patient was reported.
 
Manufacturer Narrative
It was reported that the device met specifications at the time of the inspection.It was identified that the tension of the tracks were in specification according to the manual.The inspection also identified that there were no signs of damage to the device.The alleged issue was unable to be duplicated.
 
Event Description
The customer reported that while transporting a patient down the stairs the tracks allegedly seemed loose and the stair pro felt like there was allegedly a sudden increase in motion of the chair.The customer reported that the paramedic holding the chair had to take the complete weight of the patient and has allegedly reported a knee, back, and shoulder injury requiring anti inflammatory medication.No injury to the patient was reported.
 
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 Key4538311
MDR Text Key16992684
Report Number0001831750-2015-00075
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
Report Date 02/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2015
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
-
-