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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT - OBS; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT - OBS; STRETCHER, WHEELED Back to Search Results
Catalog Number 6500000000
Device Problem Device Tipped Over (2589)
Patient Problems Abrasion (1689); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.4 devices were evaluated in the field but the issue was not confirmed; no defects or malfunctions were found.1 device is pending evaluation.There was no remedial action taken.These devices are not labeled for single use.
 
Event Description
This report summarizes 5 malfunction events, where it was reported the cot tipped.  there were 2 instances of patient involvement where no adverse consequences were reported and 2 instances where users experienced temporary pain or abrasions.
 
Manufacturer Narrative
The investigation of the final device was completed and the issue was not confirmed; no defect was found upon evaluation of the device.The device was returned to service.
 
Event Description
This report summarizes 5 malfunction events, where it was reported the cot tipped.  there were 2 instances of patient involvement where no adverse consequences were reported and 2 instances where users experienced temporary pain or abrasions.
 
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Brand Name
POWER PRO AMBULANCE COT - OBS
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10747659
MDR Text Key213458666
Report Number0001831750-2020-01150
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Number of Events Reported5
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6500000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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