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

Model Number 0015803

Device Problem Device Tipped Over (2589)

Patient Problems Abrasion (1689); Pain (1994)

Event Date 08/11/2018

Event Type  Injury  

Manufacturer Narrative

The alleged incident was reported to the manufacturer 6 months after the occurrence of the incident.A product evaluation was not conducted at the time of incident.A review of the information provided by the complainant indicates the sudden movement of the patient contributed to the alleged incident.It is unknown how many medics were operating the stretcher at the time of incident.Sufficient instructions are contained in the ifu advising of the importance of maintaining control of the stretcher while transporting a patient.

Event Description

It was reported while unloading the patient and stretcher from the ambulance and after both sets of legs were on the ground and the safety bail was released, the patient leaned to the left and the stretcher allegedly tipped to the left.The stretcher landed on its left side and the patient allegedly sustained a minor abrasion to her left hand and complained of head pain.The patient was transferred to another stretcher and returned to the emergency department for evaluation.To date, the serial number of the involved stretcher has not been provided.

• Brand Name: INX FOR INLINE
• Type of Device: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 8331054
• MDR Text Key: 135871065
• Report Number: 1523574-2019-00006
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• 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): Other
• Patient Age: 66 YR
• Patient Weight: 53