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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X PROFLEXX AMBULANCE COT
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FERNO-WASHINGTON, INC. 35X PROFLEXX AMBULANCE COT Back to Search Results
Model Number 0015710
Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 03/23/2017
Event Type  Injury  
Event Description
It was reported while loading the cot into the ambulance the legs of the cot allegedly became locked and were unable to be lifted.There were no reports of a delay in transfer or injury to the patient; however, a medic has alleged a forearm injury as a result of the incident.The initial report states the medic sought treatment in the er; however, no details of the nature of the treatment or the severity of the alleged injury were provided.
 
Manufacturer Narrative
The cot was returned to ferno and a visual and functional test was conducted.This was a 9yr old cot in fair condition and in need of repair.It was found the screw connecting the two operator handles on the release system was missing.Without this hardware the release handle will not operate properly.The user manual for the product provides preventative maintenance instructions for review of loose and missing hardware.No authorization was given to repair.The cot was returned to complainant.The complainant could not provide any further information regarding the emt's allegation of injury.
 
Event Description
It was reported while loading the cot into the ambulance the legs of the cot allegedly became locked and were unable to be lifted.There were no reports of a delay in transfer or injury to the patient; however, a medic has alleged a forearm injury as a result of the incident.The initial report states the medic sought treatment in the er; however, no details of the nature of the treatment or the severity of the alleged injury were provided.
 
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Brand Name
35X PROFLEXX AMBULANCE COT
Type of Device
35X PROFLEXX AMBULANCE COT
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
Manufacturer (Section G)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
Manufacturer Contact
dawn greene
70 weil way
wilmington, OH 45177
MDR Report Key6452984
MDR Text Key71485781
Report Number1523574-2017-00011
Device Sequence Number1
Product Code FPO
UDI-Device Identifier00190790000332
UDI-Public00190790000332
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Emergency Medical Technician
Type of Report Initial,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Emergency Medical Technician
Device Model Number0015710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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