MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. DIXIE BOARD

Model Number 0107916

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Sprain (2083); No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  No Answer Provided  

Event Description

At the scene of a car accident, a patient was being removed from a creek bed.During the removal it was alleged the top handles on the board broke.The incident created a jolt and the firefighter at the head end assumed the weight of the board and patient.The firefighter alleges back strain and was seen at the er.The firefighter did miss the remaining portion of their shift; however, has returned to work with no issues.The patient was not injured from the incident.The board is being returned for further evaluation.The customer was unable to provide the serial number of the board.

Manufacturer Narrative

The backboard was returned to manufacturer on 11/24/15 for evaluation.Upon receipt it was observed this was not a milennia board but a dixie board which was the predecessor to the milennia board.This backboard was 15+ years old at the time of incident.The board was observed to be in very poor condition with multiple cracks on the board as well as points of obvious impact.The piece that allegedly broke off was not returned with the board.The customer was provided a courtesy milennia board as a replacement so this board could be permanently removed from service.There was no further information provided regarding any adverse consequences to the patient and the emt that reported an alleged back strain returned to work the next shift and is doing well.Evidence indicates this was not a life threatening or permanent injury.

Event Description

At the scene of a car accident, a patient was being removed from a creek bed.During the removal it was alleged the top handles on the board broke.The incident created a jolt and the firefighter at the head end assumed the weight of the board and patient.The firefighter alleges back strain and was seen at the er.The firefighter did miss the remaining portion of their shift; however, has returned to work with no issues.The patient was not injured from the incident.The board is being returned for further evaluation.The customer was unable to provide the serial number of the board.

• Brand Name: DIXIE BOARD
• Type of Device: DIXIE BOARD
• 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: 5195315
• MDR Text Key: 30153785
• Report Number: 1523574-2015-00087
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0107916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 82