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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance at the hospital, the head end legs stopped at the mid-way point during the unloading process.The manual release was utilized to fully lower the head end legs so the wheels made contact with the ground.Once the stretcher was released from the hook, the head end legs allegedly lowered and the stretcher tipped to the side.The patient was assessed and no injuries were alleged as a result of the incident.The patient was removed from the stretcher and care was turned over to hospital staff.The stretcher was removed from service pending evaluation.
Additional Manufacturer Narrative
The subject stretcher was returned to manufacturer for visual and functional evaluation.It was found that the manual release cable was damaged as a result of being pinched between the actuator and upper actuator mount.The reported issue was able to be duplicated by leaving the cable in the pinched state.The manual release cable was replaced and reinstalled into the intended position away from the path of the actuator.The repaired stretcher was returned to the customer.
Event or Problem Description
It was reported while unloading a patient from the ambulance at the hospital, the head end legs stopped at the mid-way point during the unloading process.The manual release was utilized to fully lower the head end legs so the wheels made contact with the ground.Once the stretcher was released from the hook, the head end legs allegedly lowered and the stretcher tipped to the side.The patient was assessed and no injuries were alleged as a result of the incident.The patient was removed from the stretcher and care was turned over to hospital staff.The stretcher was removed from service pending evaluation.

• 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: 19019957
• Report Number: 1523574-2024-00017
• Device Sequence Number: 7981304
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)220809
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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
• Patient Sex: Unknown