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

Model Number 015803

Device Problems Device Tipped Over (2589); Unintended Movement (3026)

Patient Problem Abrasion (1689)

Event Date 04/29/2020

Event Type  Injury  

Event Description

The complainant reported while rolling the stretcher with a patient on board, the head end patient right wheel allegedly broke resulting in the stretcher lowering unexpectedly to its side.The patient alleges sustaining an arm abrasion from contacting the ground and was seen in the emergency room for evaluation.No further details were provided.

Event Description

The complainant reported while rolling the stretcher with a patient on board, the headend patient right wheel allegedly broke resulting in the stretcher lowering unexpectedly to its side.The patient alleges sustaining an arm abrasion from contacting the ground and was seen in the emergency room for evaluation.No further details were provided.

Manufacturer Narrative

An authorized field technician was dispatched to evaluate the stretcher at the complainant location.A visual evaluation was conducted and the reported issue was confirmed.The contributing factors of the broken wheel could not be determined.The stretcher was repaired and returned to service.No additional information was provided regarding the alleged patient injury.

• Brand Name: INX FOR INLINE
• Type of Device: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh
• MDR Report Key: 10048983
• MDR Text Key: 190696259
• Report Number: 1523574-2020-00013
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 015803
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84