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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED
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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 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.59 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 61 malfunction events, where it was reported the devices experienced difficulty maneuvering (no tip).There was no patient involvement.
 
Event Description
This report summarizes 60 malfunction events, where it was reported the devices experienced difficulty maneuvering (no tip).There was no patient involvement.
 
Manufacturer Narrative
Upon evaluation of one of the final devices, it was determined the device was experiencing cosmetic damage, which is not reportable.The count of events has been updated to reflect this.The final device was not made available for evaluation; the reported issue was not confirmed.
 
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Brand Name
STAIR PRO - MODEL 6252
Type of Device
STRETCHER, HAND-CARRIED
MDR Report Key12238245
MDR Text Key263816326
Report Number0001831750-2021-01216
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Number of Events Reported60
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? No
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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