MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. IN/X; IN/X FOR 175

Model Number	0015802
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/16/2016
Event or Problem Description
It was reported by a company representative the end user of the cot experienced an incident during a patient transport.While loading the patient into the ambulance, they raised the front wheels and allegedly heard a cracking sound and the cot allegedly dropped 3-6 inches while resting on the truck floor.They removed the cot from the truck and observed the retracting head end frame was broken.There were no reports of any injury on the initial complaint; however, 3 days after the initial report it was advised that a medic was alleging a shoulder injury.To date the complainant has not provided any further details regarding the alleged injury or any required medical intervention.An investigation into this complaint has been initiated and the subject cot will be returned to the manufacturer for further evaluation.
Additional Manufacturer Narrative
The device was evaluated by ferno engineering and quality representatives at the complainant' site.A visual evaluation was conducted on the cot.It was discovered the end user was applying iv tape to the telescoping frame causing a substance buildup on the frame which required the frame to be disassembled for cleaning.A field technician then conducted a preventative maintenance on the cot to clean the frame and when re-assembling the component used an incorrect shorter screw length.When the unit was placed back into operation the shorter screw allowed the telescoping frame to extend past the pin catch location and past the hard stop.When a load was applied to the frame, a bending movement potentially caused the main frame extrusion to lose structural integrity and crack.The cot was determined to be unrepairable due to the material damage and was replaced as a customer courtesy.The field technician who conducted the preventative maintenance was retrained on the proper inspection and assembly of the subject component.It was confirmed there was no injury to the patient on the cot.The medic alleging injury was reported to be off on wsib with a shoulder injury; however, no further information has been provided regarding the injury.
Event or Problem Description
It was reported by a company representative the end user of the cot experienced an incident during a patient transport.While loading the patient into the ambulance, they raised the front wheels and allegedly heard a cracking sound and the cot allegedly dropped 3-6 inches while resting on the truck floor.They removed the cot from the truck and observed the retracting head end frame was broken.There were no reports of any injury on the initial complaint; however, 3 days after the initial report it was advised that a medic was alleging a shoulder injury.To date the complainant has not provided any further details regarding the alleged injury or any required medical intervention.An investigation into this complaint has been initiated and the subject cot will be returned to the manufacturer for further evaluation.

• Brand Name: IN/X
• Common Device Name: IN/X FOR 175
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 5899814
• Report Number: 1523574-2016-00025
• Device Sequence Number: 18950466
• Product Code: FPO
• UDI-Device Identifier: 00190790000011
• UDI-Public: 00190790000011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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: Emergency Medical Technician
• Device Model Number: 0015802
• Device Catalogue Number: 0015802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1