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

Model Number	0015800
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while transporting a patient on the stretcher, the x-frame bolt allegedly broke.Neither the medic crew or the patient was injured and the patient was safely transferred to another stretcher to continue the transport.

• Brand Name: POWERFLEXX POWERED COT
• Common Device Name: POWERFLEXX POWERED COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6502980
• Report Number: 1523574-2017-00014
• Device Sequence Number: 16460504
• Product Code: FPO
• UDI-Device Identifier: 00190790000257
• UDI-Public: 00190790000257
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 04/18/2017

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: No Information
• Device Model Number: 0015800
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 85