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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. IN X, FOR INLINE

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FERNO-WASHINGTON, INC. IN X, FOR INLINE Back to Search Results
Model Number 0015803
Device Problems Mechanical Problem (1384); Power Problem (3010); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2019
Event Type  malfunction  
Event Description
Complainant alleges while attempting to unload a patient loaded stretcher, the power and manual operations would not function.The transport was completed and no injuries were reported, as a result of the incident.
 
Manufacturer Narrative
A visual and functional evaluation was conducted and the cot was found to be functioning as intended.There were no observations that would have contributed to the alleged incident.Both manual release handles were noted as working as intended.The ifu for the product provides sufficient instructions on proper loading of the cot using both the power and manual methods.
 
Event Description
Complainant alleges while attempting to unload a patient loaded stretcher, the power and manual operations would not function.The transport was completed and no injuries were reported, as a result of the incident.
 
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Brand Name
IN X, FOR INLINE
Type of Device
IN X, FOR INLINE
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
MDR Report Key8331744
MDR Text Key139078685
Report Number1523574-2019-00004
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 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0015803
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/04/2019
Initial Date FDA Received02/12/2019
Supplement Dates Manufacturer Received02/04/2019
Supplement Dates FDA Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight64
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