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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 Problem Unintended Movement (3026)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 02/25/2019
Event Type  Injury  
Event Description
It was reported while unloading a patient from the ambulance, a student rider pulled the second safety release too early and the cot advanced past the safety hook before the legs were lowered and fell to the ground with the patient.The patient was properly restrained to the stretcher.It has been alleged the patient sustained a mild compression fracture.Additional information on the alleged injury and medical intervention has not been provided.
 
Manufacturer Narrative
An authorized field technician was dispatched to the complainant's location to evaluate the stretcher.It was observed the load frame was bent in an upward postion and the backrest gas spring was broken.The safety bail was checked and found to be swinging freely as intended.The stretcher was returned to the manufacturer for necessary repairs and then returned to the complainant.The complainant confirmed the release lever was pulled too soon when unloading the patient and triggered the incident.The ifu does contain sufficient instructions on ensuring the engagement of the safety bail with the hook and the needed communication between operators when releasing the stretcher.No additional information regarding the patient's alleged injury has been provided.
 
Event Description
It was reported while unloading a patient from the ambulance, a student rider pulled the second safety release too early and the cot advanced past the safety hook before the legs were lowered and fell to the ground with the patient.The patient was properly restrained to the stretcher.It has been alleged the patient sustained a mild compression fracture.Additional information on the alleged injury and medical intervention has not 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
MDR Report Key8420434
MDR Text Key138796794
Report Number1523574-2019-00011
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0015803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2019
Date Manufacturer Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
Patient Weight160
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