MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X-ST PROFLEXX AMBULANCE COT

Model Number	0015695
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reported while transporting a patient on the cot, medic #1 lost control of the cot when his hands, wet from rain, allegedly slipped off the handles.Medic #2 attempted to assume the weight of the cot and allegedly suffered a back injury as a result.The transport was completed and there was no report of injury or adverse effect to the patient.Medic #2 was seen and treated at the er and then referred to an orthopedic physician for further care.Medic #2 will be off work for a minimum of 180 days.
Additional Manufacturer Narrative
The device was evaluated by an authorized field technician at the complainant's location.A visual and functional evaluation was conducted.No malfunction was observed and the cot was operating according to specification.No additional information was provided regarding the medic's alleged injury.After review of the investigation it is determined the weather condition was the contributing factor to the medic's hand slipping rather than a malfunction of the cot.
Event or Problem Description
Complainant reported while transporting a patient on the cot, medic #1 lost control of the cot when his hands, wet from rain, allegedly slipped off the handles.Medic #2 attempted to assume the weight of the cot and allegedly suffered a back injury as a result.The transport was completed and there was no report of injury or adverse effect to the patient.Medic #2 was seen and treated at the er and then referred to an orthopedic physician for further care.Medic #2 will be off work for a minimum of 180 days.

• Brand Name: 35X-ST PROFLEXX AMBULANCE COT
• Common Device Name: 35X-ST PROFLEXX AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6378978
• Report Number: 1523574-2017-00007
• Device Sequence Number: 773247
• Product Code: FPO
• UDI-Device Identifier: 00190790000363
• UDI-Public: 00190790000363
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 0015695
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2017
• Supplement Report FDA Received Date: 05/22/2017
• 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