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

Model Number 0015614

Device Problems Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 07/18/2017

Event Type  Injury  

Event Description

Complainant alleges while attempting to load a patient into the ambulance, the legs would not release.The cot started to tip, but the medics were able to gently guide the cot to the ground.The patient allegedly sustained a minor laceration to the elbow.It is unknown if medical treatment was sought.Medics were able to continue the transport using the same cot.

Manufacturer Narrative

The cot was evaluated by an authorized service technician on 7/21/2017.The technician inspected the stretcher and tested all functions and no mechanical issues were found.There were no bends in the frame and the ratchet bars were operating as intended when the handle was pulled.The stretcher was returned to service.The alleged event could not be duplicated.To date, no additional information pertaining to the patients alleged injury has been received.

Event Description

Complainant alleges while attempting to load a patient into the ambulance, the legs would not release.The cot started to tip, but the medics were able to gently guide the cot to the ground.The patient allegedly sustained a minor laceration to the elbow.It is unknown if medical treatment was sought.Medics were able to continue the transport using the same cot.

• Brand Name: 35-P PROFLEXX
• Type of Device: 35-P 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: 6737152
• MDR Text Key: 80864841
• Report Number: 1523574-2017-00028
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2003
• 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
• Patient Weight: 73