MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWERFLEXX POWERED AMBULANCE COT

Model Number	0015796
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged the cot was coming loose from the ambulance fastener when the ambulance would make left hand turns.There were no reports of this alleged issue occuring during a patient transport and no injuries were reported as a result of the issue.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainant's site.The cot was found to be operating as intended and no malfunctions were found.The ambulance fastening system was also evaluated and it was discovered a component of the fastener was installed incorrectly.The reported issue was able to be duplicated as a result.The subject fastener was repaired and verified as functioning according to specification.Both the cot and fastener were returned to service.There was no patient involvement reported at the time of the incident.
Event or Problem Description
It was alleged the cot was coming loose from the ambulance fastener when the ambulance would make left hand turns.There were no reports of this alleged issue occuring during a patient transport and no injuries were reported as a result of the issue.

• Brand Name: POWERFLEXX POWERED AMBULANCE COT
• Common Device Name: POWERFLEXX POWERED AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6883696
• Report Number: 1523574-2017-00035
• Device Sequence Number: 496462
• Product Code: FPO
• UDI-Device Identifier: 00190790000226
• UDI-Public: 00190790000226
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/18/2017

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: 0015796
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1