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

Model Number 0015803

Device Problems Unintended Movement (3026); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 11/06/2017

Event Type  Injury  

Event Description

Complainant alleges while transporting the patient to the ambulance, the medics maneuvered the cot around to align it with the back of the ambulance when the cot tilted on its side.The assisting medics and patient sustained injuries as a result.All were "seen" in the emergency room and released.No additional information was provided.

Manufacturer Narrative

The cot was evaluated at the complainant's location by an authorized field technician.A visual and functional evaluation was conducted on the cot and no malfunctions were found and the cot was operating according to specification.It was observed a telescoping handle on the cot was bent as a result of the incident.This handle was replaced.Details gathered on the alleged injuries are as follows: medic 1 - back injury, medic 2 - back injury; assisting operator 1 - wrist injury; assisting operator 2 - elbow injury and patient - skin tear to elbow.It was reported assisting operator 1 did seek medical intervention and was placed off work for 2 days.No additional details were provided on the other alleged injuries or if medical intervention was necessary.The complainant advised the patient did not make any sudden movements and the medic crew was transporting the patient in the load positon rather than the transport position.It was also reported the ground surface at the time of transport was a concrete surface with noted cracks.After review of the investigation it is determined a malfunction of the cot did not contribute to the reported incident.The ifu and training videos for the product provide sufficient instructions and cautions on the proper cot height for transporting patients and for maintaining control of the cot while operating the cot.

Event Description

Complainant alleges while transporting the patient to the ambulance, the medics maneuvered the cot around to align it with the back of the ambulance when the cot tilted on its side.The assisting medics and patient sustained injuries as a result.All were seen i the emergency room and released.No additional information was provided.

• 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 ; 9372832900
• MDR Report Key: 7024227
• MDR Text Key: 91771076
• Report Number: 1523574-2017-00047
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• 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
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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 Outcome(s): Other
• Patient Weight: 159