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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT; STRETCHER, WHEELED Back to Search Results
Catalog Number 6506000000
Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
Patient Problems Head Injury (1879); Hematoma (1884)
Event Date 12/15/2016
Event Type  Death  
Event Description
It was reported that the cot was involved in an ambulance accident while transporting a patient.It was further reported that the shoulder straps were missing from the cot (inadequate patient restraints).The missing straps allowed the patient to be ejected from the cot, causing him to hit his head, leading to a hematoma above the eye which required a ct scan.No further medical intervention was reported, and the patient was then transported for treatment of his original issue.
 
Manufacturer Narrative
Information has been received reporting that the patient involved in this event has passed away.
 
Event Description
It was reported that the cot was involved in an ambulance accident while transporting a patient.It was further reported that the shoulder straps were missing from the cot (inadequate patient restraints).The missing straps allowed the patient to be ejected from the cot, causing him to hit his head, leading to a hematoma above the eye which required a ct scan.No further medical intervention was reported, and the patient was then transported for treatment of his original issue.
 
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Brand Name
POWER PRO 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 Key6249138
MDR Text Key64744503
Report Number0001831750-2017-00013
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 Health Care Professional
Type of Report Initial,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6506000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/10/2014
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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