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

Model Number	0015803
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stretcher was evaluated at the customer location.As a result of the impact from the crash, multiple observations of damage to the stretcher and fastener were found and it was recommended both the stretcher and fastener be removed from service.
Event or Problem Description
It was reported an ambulance was involved in a high speed head on collision while transporting a patient.Statements indicate the stretcher remained locked in the fastener during impact.The patient allegedly "moved upward" on the stretcher as a result of the shoulder restraints not being used during the transport.An allegation of patient injury has been made; however, details confirming patient injury have not been received.There has been no allegation of product malfunction being a factor in the reported incident and alleged injury.It has been recommended this stretcher and the associated fastener be removed from service.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 10818324
• Report Number: 1523574-2020-00024
• Device Sequence Number: 1667805
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/10/2020

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: 0015803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other