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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance, the stretcher began falling to the left side as if the wheels on the ambulance deck were uneven.The second release was not lifted; however, the stretcher continued tipping to the left and lowered from the ambulance deck to the ground.The patient was not injured but did need to be removed from the stretcher and the transport was continued on another stretcher.A medic has alleged injury in the form of a hand sprain and sought physical therapy.
Event or Problem Description
It was reported while unloading a patient from the ambulance, the stretcher began falling to the left side as if the wheels on the ambulance deck were uneven.The second release was not lifted; however, the stretcher continued tipping to the left and lowered from the ambulance deck to the ground.The patient was not injured but did need to be removed from the stretcher and the transport was continued on another stretcher.A medic has alleged injury in the form of a hand sprain and sought physical therapy.
Additional Manufacturer Narrative
An authorized field technician was dispatched to the customer's location to conduct a visual and functional evaluation.After the evaluation there was no observation of component malfunction that would have contributed to the reported incident and the stretcher was operating as intended.The reported issue could not be confirmed.The stretcher was returned to service.

• 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: 19217717
• Report Number: 1523574-2024-00038
• Device Sequence Number: 8198488
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)230224
• 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): 07/22/2024

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: 04/26/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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: 64 YR
• Patient Sex: Female