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

Model Number 0015690

Device Problems Difficult to Fold, Unfold or Collapse (1254); Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

The emt unit was attempting to unload a pt with a knee injury was unable to get the legs to release on the cot.

Manufacturer Narrative

Upon review of the service eval, it was agreed that the incident was not a fault of a mfg defect, but rather the lack of a maintenance plan.We are reporting the event though due to the interruption in service.

• 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: 3925283
• MDR Text Key: 17277341
• Report Number: 1523574-2014-00010
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0015690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2013
• 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 Age: 46 YR