MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 93-H PROFLEX

Model Number 0015748

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 01/17/2019

Event Type  Injury  

Event Description

Complainant alleges while unloading a patient from the ambulance the legs of the cot were not verified to be locked and when the cot was pulled from the track the legs allegedly lowered and the cot tipped to the side.It was reported the patient allegedly sustained minor injuries.

Manufacturer Narrative

The cot was evaluated by an authorized field technician at the complainants site.A visual and functional evaluation was conducted.The technician found the stretcher to be in proper working order and was unable to duplicate the alleged issue.The ifu provides clear instruction for proper unloading of the cot and states multiple times to verify the undercarriage has been locked into position before operating the fastener release lever or release handle.No further details were provided pertaining to the alleged patient injury or if any further intervention was sought.

Event Description

Complainant alleges while unloading a patient from the ambulance the legs of the cot were not verified to be locked and when the cot was pulled from the track, the legs allegedly lowered and the cot tipped to the side.It was reported the patient allegedly sustained minor injuries.

• Brand Name: 93-H PROFLEX
• Type of Device: 93-H PROFLEX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8355846
• MDR Text Key: 136723807
• Report Number: 1523574-2019-00007
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015748
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other