MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. INX FOR INLINE WITH DWL

Model Number 0015811

Device Problems Device Tipped Over (2589); Unintended Movement (3026)

Patient Problems Abrasion (1689); Pain (1994)

Event Date 01/03/2020

Event Type  Injury  

Event Description

The complainant reported after unloading the patient from the ambulance, the medics were lowering the cot to transport position and the cot allegedly began to lean to the right and tip over.The patient allegedly sustained an abrasion to the right elbow and shoulder.A medic is alleging should pain.Both the patient and medic were examined and xrays on both were performed.No additional details have been provided.

Manufacturer Narrative

An authorized field technician was dispatched to evaluate the stretcher at the complainant's location.A visual evaluation was conducted and it was confirmed the leg bracket was damaged but could not be repaired onsite.The stretcher was returned to the manufacturer.Manufacturer was contacted by legal counsel to preserve the stretcher in its current state.The complainant was provided a replacement stretcher.No additional information has been received regarding the alleged patient and medic injuries.

Event Description

The complainant reported after unloading the patient from the ambulance, the medics were lowering the cot to transport position and the cot allegedly began to lean to the right and tip over.The patient allegedly sustained an abrasion to the right elbow and shoulder.A medic is alleging shoulder pain.Both the patient and medic were examined and xrays on both were performed.No additional details have been provided.

• Brand Name: INX FOR INLINE WITH DWL
• Type of Device: INX FOR INLINE WITH DWL
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh OH 45177
• MDR Report Key: 9578162
• MDR Text Key: 174665597
• Report Number: 1523574-2020-00002
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: 00190790001339
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 01/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 204