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

Model Number 0015803

Device Problem Unintended Movement (3026)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 04/13/2022

Event Type  Injury  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 289679527
• Report Number: 1523574-2022-00006
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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 Sex: Female
• Patient Weight: 181 KG