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

Model Number	0015729
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while transporting a patient, a wheel detached from the cot.It was further reported that the cot tipped over with the patient.The patient allegedly sustained injuries, however no details have been provided.
Additional Manufacturer Narrative
The cot was evaluated by an authorized service technician.Upon evaluation of the cot it was discovered the screws on the wheel had not been repaired according to specifications as there was no loctite visible and the screws were only hand tightened.The wheel of the cot was repaired as was all other unrelated observed maintenance deficiencies and the cot was returned to service.The complainant advised the alleged wheel had been previously replaced by an unauthorized service technician prior to the reported incident.The complainant confirmed the cot had not received regular preventative maintenance services since being put into service and had previously been repaired by an unauthorized field technician.It is determined that the alleged incident was a result of improper installation and repair of the wheel by the unauthorized technician.The user manual provides clearn instructions for preventative maintenance and inspecting the cot for loose hardware.No further information has been received pertaining to the patient's alleged injury.
Event or Problem Description
It was reported while transporting a patient, a wheel detached from the cot.It was further reported that the cot tipped over with the patient.The patient allegedly sustained injuries, however no details have been provided.

• Brand Name: POWERFLEXX POWERED COT
• Common Device Name: POWERFLEXX POWERED COT
• Manufacturer (Section D): FERNO-WASHINGON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6516956
• Report Number: 1523574-2017-00016
• Device Sequence Number: 1594606
• Product Code: FPO
• UDI-Device Identifier: 00190790000202
• UDI-Public: 00190790000202
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: 0015729
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82