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

Model Number 0015790

Device Problems Retraction Problem (1536); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 35 XST PROFLEXX
• 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 Key: 6918321
• MDR Text Key: 89853991
• Report Number: 1523574-2017-00039
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 00190790000585
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 181