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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance the foot end medic allegedly pulled the stretcher from the ambulance prior to ensuring the head end legs were fully lowered and the stretcher lowered from ambulance deck but did not tip.The patient complained of back pain as a result and was evaluated at the hospital.No further details were provided.
Additional Manufacturer Narrative
The subject stretcher was returned to the manufacturer for a visual and functional evaluation.There were no observations made that would have contributed to the reported incident.Unrelated maintenance observations were made and repaired prior to return to customer.The contributing factor of the incident is being attributed to unintentional use error.
Event or Problem Description
It was reported while unloading a patient from the ambulance the foot end medic allegedly pulled the stretcher from the ambulance prior to ensuring the head end legs were fully lowered and the stretcher lowered from ambulance deck but did not tip.The patient complained of back pain as a result and was evaluated at the hospital.No further details were provided.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 wiel way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 18267915
• Report Number: 1523574-2023-00043
• Device Sequence Number: 3956044
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)230216
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/02/2024

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: 0015811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 95 KG