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

Model Number 0015803

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); No Code Available (3191)

Event Date 05/19/2017

Event Type  Injury  

Event Description

Complainant reported while the medic team was pulling a patient from the ambulance, the footend operator did not verify the head end legs had been lowered to the ground and continued to pull the cot from the ambulance.The head end of the stretcher fell to the ground.The patient was startled and later alleged a headache; however, no other injuries were noted.It is unknown if medical intervention was sought for the alleged headache.The complainant reported this was a result of user error and not a malfunction of the cot.

Manufacturer Narrative

The cot was evaluated by an authorized field technician at the complainant's location.A visual evaluation was conducted and the alleged issue was confirmed.The backrest was repaired and the cot was returned to service.It was determined the contributing factor to the incident was user error during the unloading process.Sufficient instructions are contained in the user manual to ensure safe unloading of a patient from an ambulance.No additional information has been provided regarding the alleged patient headache or necessary medical intervention.

Event Description

Complainant reported while the medic team was pulling a patient from the ambulance, the footend operator did not verify the head end legs had been lowered to the ground and continued to pull the cot from the ambulance.The head end of the stretcher fell to the ground.The patient was startled and later alleged a headache; however, no other injuries were noted.It is unknown if medical intervention was sought for the alleged headache.The complainant reported this was a result of user error and not a malfunction of the cot.

• Brand Name: INX FOR INLINE
• Type of Device: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177
• MDR Report Key: 6582843
• MDR Text Key: 75691574
• Report Number: 1523574-2017-00020
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 0019079000004
• UDI-Public: (01)0019079000004(11)160927
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: 05/17/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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: 79 YR