MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35-ANM COT NON-MAGNETIC

Model Number	0015612
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant reported while attempting to raise the stretcher with a patient on board, the legs would allegedly not engage.The patient allegedly hit their head on the nearby mri equipment and complained of neck and head pain, but did not seek medical intervention.
Event or Problem Description
The complainant reported while attempting to raise the stretcher with a patient on board, the legs would allegedly not engage.The patient allegedly hit their head on the nearby mri equipment and complained of neck and head pain, but did not seek medical intervention.
Additional Manufacturer Narrative
An authorized field technician was dispatched to evaluate the cot.A visual and functional evaluation was conducted; however, the technician was unable to identify a cause for the reported issue.The cot was returned to the manufacturer for further evaluation.Another functional evaluation was completed and the cot performed according to specification.The reported issue could not be duplicated.The ifu provides clear instruction on proper operation of the cot while lowering and raising to ensure a locked position as well as proper restraint of patients to minimize movement while transporting.No additional information on the alleged patient injury has been provided.

• Brand Name: 35-ANM COT NON-MAGNETIC
• Common Device Name: 35-ANM COT NON-MAGNETIC
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 10108850
• Report Number: 1523574-2020-00017
• Device Sequence Number: 11543865
• Product Code: FPO
• UDI-Device Identifier: 00190790000042
• UDI-Public: 00190790000042
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0015612
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 101