MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35 XST PROFLEXX

Model Number	0015790
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to load the patient, the crew was unable to retract the undercarriage.The patient was transferred to another cot and transported.No injuries were reported.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainant's site.A visual and functional evaluation was conducted and there was no observation of any malfunction.The cot was functioning according to specification and the reported incident could not be duplicated.It was observed the crew was operating the release system incorrectly.This type of cot is new to the service and the release system is operated differently than their prior product.While onsite, the technician showed the crew the proper loading technique for this cot.The complainant did advise the cot was able to be operated correctly after the reported incident and it was never removed from service.The ifu for the cot provides sufficient instructions on how to operate the release mechanism to raise the undercarriage during the loading process.
Event or Problem Description
Complainant alleged while attempting to load the patient, the crew was unable to retract the undercarriage.The patient was transferred to another cot and transported.No injuries were reported.

• Brand Name: 35 XST PROFLEXX
• Common Device Name: 35 XST PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6918321
• Report Number: 1523574-2017-00039
• Device Sequence Number: 1223808
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 00190790000585
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: Emergency Medical Technician
• Device Model Number: 0015790
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 181