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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Abrasion (1689); Laceration(s) (1946)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported while rolling the stretcher with a patient to the ambulance, the wheels allegedly became stuck on the uneven surface of the parking lot and sidewalk, the stretcher began to lean and then tip over.The patient remained restrained to the stretcher and there was no allegation of patient injury other than the patient's elbow scraping the ground.Although there was no allegation of a product malfunction, as a precaution, the patient was transferred to another stretcher to continue the transport.No additional information has been provided.
Event or Problem Description
The customer reported while rolling the stretcher with a patient to the ambulance, the wheels allegedly became stuck on the uneven surface of the parking lot and sidewalk and the stretcher began to lean and then tip over.The patient remained restrained to the stretcher and there was no allegation of patient injury other than the patient's elbow scraping the ground.Although there was no allegation of a product malfunction, as a precaution, the patient was transferred to another stretcher to continue the transport.No additional information has been provided.
Additional Manufacturer Narrative
The stretcher was returned to manufacturer for evaluation.A visual and functional evaluation was conducted and there were no observations of mechanical issues that would have contributed to the reported incident.The stretcher was functioning as intended; however, strike marks were noted as a result of the tip.The rough surface of the pavement interupting the motion of the transport wheels is the direct contributing factor to the incident.No additional information was provided regarding the patient's alleged injury.

• Brand Name: INX, FOR INLINE
• Common Device Name: INX, FOR INLINE
• 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 ; 9372832900
• MDR Report Key: 14161635
• Report Number: 1523574-2022-00006
• Device Sequence Number: 5609063
• 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,Followup
• Report Date (Section B): 07/11/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 181 KG