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

Model Number 005790

Device Problems Positioning Failure (1158); Device Tipped Over (2589); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

The complainant reported 2 medics were transporting a patient on a cot up a flight of stairs.When they reached the landing the medics attempted to release the legs; however, the legs allegedly did not lower and the cot started to tip.Both medics are allegedging injuries as a result.There was no report of the patient being injured.No details have been provided by the complainant.

Manufacturer Narrative

The cot was evaluated by an authorized field technician at the complainant's location.A visual and functional evaluation was conducted and no malfunctions were observed and the cot was operating according to specification.It was found the operators of the cot were not releasing the weight from the ratchet system prior to pulling the release handle as instructed in the ifu.By carrying the cot up the staircase with all four wheels off the ground the cot's locking system was fully engaged and in order to release the lock the undercarriage would have needed to be lifted slightly to release the pressure.The reported scenario involving the staircase would have required an additional helper to assist in properly releasing the leg system.The field technician consulted with the complainant to ensure they understood the intended function and operation of the ratchet release system.The complainant advised medic 1 alleged a minor wrist sprain/bruised knee and medic 2 alleged they fell backwards on their back but no details of the injuries or required medical intervention was provided.It was reported both medics returned to work after the incident.There have been no allegation of adverse effects or injury to the patient.A review of the ifu for the cot reveals sufficient instruction of the operation of the ratchet/locking system when moving the legs of the cot between positions.

Event Description

The complainant reported 2 medics were transporting a patient on a cot up a flight of stairs.When they reached the landing the medics attempted to release the legs; however, the legs allegedly did not lower and the cot started to tip.Both medics are alleging injuries as a result.There was no report of the patient being injured.No details have been provided by the complainant.

• 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: 7088764
• MDR Text Key: 93907146
• Report Number: 1523574-2017-00053
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 005790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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