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

Model Number 0012079

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  Injury  

Event Description

Complainant reported while unloading the stretcher from the ambulance, the cot drifted and the patient began moving suddenly allowing the stretcher to tip.The medic crew then transferred the patient to a hospital bed for evaluation.No injuries and/or medical intervention have been reported at the time of this report.

Event Description

Complainant reported while unloading the stretcher from the ambulance, the cot drifted and the patient began moving suddenly alowing the stretcher to tip.The medic crew then transferred the patient to a hospital bed for evaluation.No injuries and/or medical intervention have been reported at the time of this report.

Manufacturer Narrative

A visual and functional evaluation was conducted on the subject cot and the reported issue was not able to be duplicated.No malfunctions were observed and the cot was operating according to specification.The ifu for the product provides sufficient instructions on maintaining control of the cot while unloading a patient.The complainant has not provided any further details to whether the patient sustained an injury or if medical intervention was sought.

• Brand Name: 35-A AMBULANCE COT
• Type of Device: 35-A AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8776951
• MDR Text Key: 150592225
• Report Number: 1523574-2019-00025
• 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: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0012079
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 218