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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 Handling Problem (3265)
Patient Problem Injury (2348)
Event Date 08/09/2016
Event Type  malfunction  
Event Description
It was alleged that there was an injury during use of the device.The emt was transporting the patient and let the foot end side of the device down, causing the device to not catch and miss the safety hook.Information was not provided on whether the patient or the user received the injury and no information was provided on the type of injury.
 
Manufacturer Narrative
There was no injury to the patient and no medical intervention required for the alleged injury to the user and no time off from work was required.
 
Event Description
It was alleged that there was an injury during use of the device.The emt was transporting the patient and let the foot end side of the device down, causing the device to not catch and miss the safety hook.
 
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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
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 Key5935857
MDR Text Key54178378
Report Number0001831750-2016-00282
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6500000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2008
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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