MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X PROFLEXX X FRAME COT

Model Number 0015710

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The device was evaluated and function tested.No malfunctions were detected and the reported incident could not be duplicated.The cot was returned to the customer with a recommendation to review the user manual with staff as the release mechanism should be engaged prior to pulling from the truck.There were no injuries or consequences to the patient and the transport was able to be completed.No further information pertaining to the emt's alleged injury or medical intervention sought could be obtained.

Event Description

It was reported that while unloading a patient from the truck the legs of the cot would not release to lower down.The emt at the foot end had to elevate the cot to enable the legs to release.When the emt raised the cot he allegedly felt "something pull" in his lower back.The legs were able to be lowered and the transport continued without any further incident and no impact or injury to the patient.It is unknown if the emt sought medical intervention.

• Brand Name: 35X PROFLEXX X FRAME COT
• Type of Device: 35X PROFLEXX X FRAME 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 Key: 5271569
• MDR Text Key: 32827714
• Report Number: 1523574-2015-00090
• Device Sequence Number: 1
• Product Code: FPO
• 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
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015710
• Device Catalogue Number: PT3570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• 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 Outcome(s): Other