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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	08/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading the stretcher from the ambulance, the patient made a sudden move to the right causing the safety bail to miss the hook and the stretcher lowered from the ambulance and tipped to the right side.It was alleged the patient sustained an elbow and toe injury and both operating medics alleged arm/wrist injury.The patient and medics were evaluated in the er; however, no further details were provided on outcome or treatment.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted by an authorized field technican at the customer's location.The strecher was found to be operating as intended; however, minor damage was noted to the display attachment, presumably as a result of the incident.The stretcher was repaired and returned to service.Cause of the incident is attributed to the patient's reported sudden movement during the unloading process.
Event or Problem Description
It was reported while unloading the stretcher from the ambulance, the patient made a sudden move to the right causing the safety bail to miss the hook and the stretcher lowered from the ambulance and tipped to the right side.It was alleged the patient sustained an elbow and toe injury and both operating medics alleged arm/wrist injury.The patient and medics were evaluated in the er; however, no further details were provided on outcome or treatment.

• 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: 17711769
• Report Number: 1523574-2023-00036
• Device Sequence Number: 20520409
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)220706
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/04/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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: Male
• Patient Weight: 156 KG