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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
While attempting to load a bariatric patient into the ambulance, the head end left wheel was not aligned with the vehicle and when the stretcher was raised to loading position the operator end of the stretcher began rolling to the patient's left due to the slope of the ground.While attempting to stop the roll and push the stretcher forward, the stretcher tipped over to the patient's right side.The patient was evaluated and no injury was reported.The incident report did note an allegation of injury to a medic in the nature of soreness and bruising and that medical evaluation was sought.No additional information was provided.
Additional Manufacturer Narrative
The customer opted out of an evaluation of the stretcher as there was no allegation of product malfunction contributing to the incident.A followup inquiry was made to the customer and they confirmed the stretcher remains in service and it has been working properly following the reported incident.
Event or Problem Description
While attempting to load a bariatric patient into the ambulance, the head end left wheeel was not aligned with the vehicle and when the strecher was raised to loading position the operator end of the stretcher began rolling to the patient's left due to the slope of the ground.While attempting to stop the roll and push the stretcher forward, the stretcher tipped over to the patient's right side.The patient was evaluated and no injury was reported.The incident report did note an allegation of injury to a medic in the nature of soreness and bruising and that medical evaluation was sought.No additional information was provided.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmlngton OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmlngton OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmlngton, OH 45177
• MDR Report Key: 16463599
• Report Number: 1523574-2023-00001
• Device Sequence Number: 20476212
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0015803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 277 KG