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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 Difficult or Delayed Positioning (1157)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2022
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.97 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 99 malfunction events, where it was reported the devices experienced difficult to maneuver unit (no tip).There was 1 event with patient involvement; no adverse consequences were reported.
 
Event Description
This report summarizes 99 malfunction events, where it was reported the devices experienced difficult to maneuver unit (no tip).There was 1 event with patient involvement; no adverse consequences were reported.
 
Manufacturer Narrative
The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.
 
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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
brandon luckas
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key15666899
MDR Text Key305007997
Report Number0001831750-2022-01047
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported99
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
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 Received10/01/2022
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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