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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MX-PRO R-3 AMBULANCE COT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO MX-PRO R-3 AMBULANCE COT; STRETCHER, WHEELED Back to Search Results
Catalog Number 6082000000
Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)
Patient Problem Extubate (2402)
Event Date 04/03/2019
Event Type  malfunction  
Event Description
It was reported that the patient was being removed from the back of a helicopter when the right load wheel came out first and then the cot tipped over dropping the patient.It was reported that while there were no injuries to the patient, the patient was extubated, due to the tip.It was reported that the event was due to a user error because the operators were not correctly supporting the patient load as the cot had exited the helicopter.
 
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Brand Name
MX-PRO R-3 AMBULANCE COT
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 Key8568814
MDR Text Key143940434
Report Number0001831750-2019-00559
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327261547
UDI-Public07613327261547
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
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number6082000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2013
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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