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

Model Number	0015654
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an ambulance was involved in a motor vehicle accident where it was impacted on the passenger side by another vehicle traveling about 35 mph.It is alleged at the time of impact the cot released from the antler and the cot shifted to the patient's right side and the patient struck their head on a cabinet causing a laceration.The patient remained secured on the cot throughout the accident.The patient was treated for the laceration and another medic was called to continue the transport of the patient.No additional information has been provided on the patient.An investigation of this incident has been initiated.
Additional Manufacturer Narrative
The fastening system and cot were evaluated by an authorized field technician at the complainant's site.It was observed the cot would not lock into the fastener unless manually pulled.The fastening system was replaced and returned to service.The cot was also evaluated and it was observed the patient right side arm rail and release was bent.The side arm rail and release was replaced and the cot was returned to service.No further information was provided regarding the patient's alleged injury.
Event or Problem Description
It was reported an ambulance was involved in a motor vehicle accident where it was impacted on the passenger side by another vehicle traveling about 35 mph.It is alleged at the time of impact the cot released from the antler and the cot shifted to the patient's right side and the patient struck their head on a cabinet causing a laceration.The patient remained secured on the cot throughout the accident.The patient was treated for the laceration and another medic was called to continue the transport of the patient.No additional information has been provided on the patient.An investigation of this incident has been initiated.

• 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: 6345486
• Report Number: 1523574-2017-00006
• Device Sequence Number: 1042368
• Product Code: FPO
• UDI-Device Identifier: 00190790000189
• UDI-Public: 00190790000189
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/07/2017

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: 0015654
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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