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

Model Number 0015811

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2023

Event Type  Death  

Event Description

A ferno sales representative received a communication alleging a ferno stretcher was involved in a rollover ambulance accident resulting in a patient death.The accident was not reported to ferno at the time of occurrence and involvement of the alleged ferno stretcher has not been confirmed.There have been no reports of alleged product malfunction being a factor in the alleged incident.An online article stated " the transit van left the roadway and rolled; there was snow and ice on the freeway at the time of the accident".No further details have been provided.

• Brand Name: INX
• Type of Device: INX
• 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
• MDR Report Key: 17035017
• MDR Text Key: 316277832
• Report Number: 1523574-2023-00014
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 0015811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Sex: Female