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

Model Number 0015710

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 11/06/2017

Event Type  Injury  

Event Description

The complainant alleges while transporting a patient in the ambulance, the stretcher came loose from the fastener and rolled over the foot of a passenger riding in the back allegedly sustaining a foot injury as a result and was evaluated at the hospital.No further details were provided.

Manufacturer Narrative

The cot and fastener were returned to manufacturer for evaluation.A visual and functional evaluation of both products was conducted and revealed no malfunctions of either product or their interaction with each other.It could not be confirmed if the end user verified the cot was fully engaged with the fastening system after they loaded the cot.A review of the ifu for both products reveals detailed instructions on proper loading and locking of the cot into the fastener as well as verification of the locked position to ensure a safe transport of a patient in the back of the ambulance.The complainant has not provided any further details regarding the alleged passenger foot injury or any additional medical intervention required.

Event Description

The complainant alleges while transporting a patient in the ambulance, the stretcher came loose from the fastener and rolled over the foot of a passenger riding in the back allegedly sustaining a foot injury and was evaluated at the hospital.No further details were provided.

• Brand Name: 35X PROFLEXX
• Type of Device: 5X 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: 7033453
• MDR Text Key: 92089001
• Report Number: 1523574-2017-00050
• 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,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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