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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. INX FOR INLINE
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FERNO-WASHINGTON, INC. INX FOR INLINE Back to Search Results
Model Number 0015803
Device Problems Device Tipped Over (2589); Device Handling Problem (3265)
Patient Problem Skin Tears (2516)
Event Date 11/22/2017
Event Type  Injury  
Event Description
The complainant alleges while transporting a patient, the device came in contact with a landscaping paver while navigating down a set of porch steps and then tipped over.The patient sustained a minor skin tear.The crew was able to complete the transport.No further details have been provided.
 
Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainant's location.A visual and functional evaluation was conducted and no malfunctions were noted and the cot was operatoring according to specification.After review of the investigation it is determined a malfunction of the cot was not the contributing factor to the incident but rather a loose paver catching the wheel of the stretcher and creating an obstruction.The ifu for the cot provides sufficient instructions and cautions for the proper operation of the cot around potential obstructions during a patient transport and proper placement of the medic crew and cot height to ensure a controlled and safe transport.The complainant did not have any additional information regarding the alleged patient injury and medical intervention required other than wound cleaning and a bandaid.
 
Event Description
The complainant alleges while transporting a patient, the device came in contact with a landscaping paver while navigating down a set of porch steps and then tipped over.The patient sustained a minor skin tear.The crew was able to complete the transport.No further details have been provided.
 
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Brand Name
INX FOR INLINE
Type of Device
INX FOR INLINE
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
9372832900
MDR Report Key7067194
MDR Text Key93213291
Report Number1523574-2017-00052
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 other
Reporter Occupation Emergency Medical Technician
Type of Report Initial,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Emergency Medical Technician
Device Model Number0015803
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2016
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;
Patient Age79 YR
Patient Weight82
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