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

Model Number 0015811

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/20/2019

Event Type  malfunction  

Event Description

The complainant reported while lowering the cot into position to load a patient, the cot allegedly made a crunching sound and the cot would not function.The medics were able to load the cot back into the ambulance; however they made the decision to walk the patient to the ambulance for final transport.At the hospital, a backup unit was used to complete the transfer into the hospital.There were no adverse effects or delay as a result.

Event Description

The complainant reported while lowering the cot into position to load a patient, the cot allegedly made a crunching sound and the cot would not function.The medics were able to load the cot back into the ambulance; however they made the decision to walk the patient to the ambulance for final transport.At the hospital, a backup unit was used to complete the transfer into the hospital.There were no adverse effects or delay as a result.

Manufacturer Narrative

The device was returned to ferno for evaluation.A visual and functional evaluation was conducted.The root cause was attributed to the improper mounting of the iv pole to the cot.The iv pole was mounted over a storage net which allowed the pole to get caught in the leg of the cot damaging the composite arms and the sensors.The cot was repaired and approved for service.No further details were provided regarding the patient's alleged injury.

• 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 45177
• MDR Report Key: 9578116
• MDR Text Key: 188336103
• Report Number: 1523574-2020-00001
• 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: 02/07/2020

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: 01/09/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 82