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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X NM COT
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FERNO-WASHINGTON, INC. 35X NM COT Back to Search Results
Model Number 0015788
Device Problems Malposition of Device (2616); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2015
Event Type  malfunction  
Event Description
The customer reported when they received the non-magnetic cot the locking caster wheels were in the incorrect position and they did not feel the cot was safe for the mri.The customer was contacted and they alleged they felt the wheel assemblies were magnetic.There was no patient involvement and the cot was not put into service.An investigation has been opened and the cot is being returned to ferno for immediate evaluation.Details of the evaluation will be provided in a supplemental report.
 
Manufacturer Narrative
Upon receipt of the initial complaint the product line was temporarily placed on hold until the subject unit could be returned to ferno for evaluation.Existing inventory was checked and it was confirmed there were no affected units in inventory.The unit was returned on 9/3/2015 and was evaluated for the alleged malfunction.It was confirmed the casters on the cot were not to specification; however, all other components were correct according to the design specifications.The casters were replaced and the cot was returned to the end user.The incident was reviewed with the appropriate manufacturing personnel and a quality alert was issued to the assembly cell.The product was released from the hold.
 
Event Description
The customer reported when they received the non-magnetic cot the locking caster wheels were in the incorrect position and they did not feel the cot was safe for the mri.The customer was contacted and they alleged they felt the wheel assemblies were magnetic.There was no patient involvement and the cot was not put into service.An investigation has been opened and the cot is being returned to ferno for immediate evaluation.Details of the evaluation will be provided in a supplemental report.
 
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Brand Name
35X NM COT
Type of Device
35X NM 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
9372832900
MDR Report Key5039699
MDR Text Key25220276
Report Number1523574-2015-00081
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 health professional,other
Reporter Occupation Hospital Service Technician
Type of Report Followup
Report Date 05/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Hospital Service Technician
Device Model Number0015788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2015
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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