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

Model Number	015803
Medical Device Problem Codes	Device Tipped Over (2589); Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh
• MDR Report Key: 10048983
• Report Number: 1523574-2020-00013
• Device Sequence Number: 3293275
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 015803
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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
• Patient Weight: 84