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

Model Number 0015710

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem Injury (2348)

Event Date 07/17/2014

Event Type  Injury  

Event Description

While unloading a large patient from the ambulance, it was reported that the stretcher wheels did not deploy completely.It was also reported that the patient shifted their weight on the stretcher causing the stretcher to tip to the patient's right.It was noted that the patient injured his right arm and right shoulder from the impact of the ground.There was no disclosure of medical treatment sought for the stated injuries.

Manufacturer Narrative

The unit was evaluated and there were no signs of missing or damaged parts.The unit was cycled up and down with no issues.The unit was then tested to mimic unloading, using both the side and foot end release handles, multiple times and the unit functioned as intended.The incident could not be duplicated.

• Brand Name: 35X PROFLEXX AMBULANCE COT
• Type of Device: 35X PROFLEXX AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; wilmington OH
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 4044761
• MDR Text Key: 15996555
• Report Number: 1523574-2014-00014
• 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: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015710
• Device Catalogue Number: PT3570
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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
• Patient Age: 56 YR