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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Laceration(s) (1946); Unspecified Tissue Injury (4559)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance the safety bail did not engage with the hook and the stretcher lowered to the bumper and then tipped to the ground.It was discovered an obstruction was covering the safety hook which caused the safety bail to not engage with the hook.It was reported the patient sustained injury to the head and right shoulder as a result of contacting the ground.The nature of injuries was described as laceration and soft tissue injury.
Additional Manufacturer Narrative
The customer contacted their service provider to conduct a pm evaluation on the stretcher.Damage as a result of the reported incident was observed.The reported obstruction over the safety hook is attributed as the contributing factor to the incident.
Event or Problem Description
It was reported while unloading a patient from the ambulance the safety bail did not engage with the hook and the stretcher lowered to the bumper and then tipped to the ground.It was discovered an obstruction was covering the safety hook which caused the safety bail to not engage with the hook.It was reported the patient sustained injury to the head and right shoulder as a result of contacting the ground.The nature of injuries was described as laceration and soft tissue injury.

• Brand Name: INX FOR INLINE WITH DWL
• Common Device Name: INX FOR INLINE WITH DWL
• 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 ; 9372832900
• MDR Report Key: 16613211
• Report Number: 1523574-2023-00006
• Device Sequence Number: 4931527
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)180125
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2023

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: 0015811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 07/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 91 KG