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

Model Number	0015654
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Physical Entrapment (2327)
Date of Event	09/30/2016
Event or Problem Description
It was reported while onsite for a non-emergency bariatric patient transport the cot would allegedly not work in power mode.The crew replaced the powerpac with an extra pac they had with them.While both medics were reaching under the cot to connect the new powerpac, the cot allegedly lowered approx 6 inches trapping their arms beneath the cot.It was also reported the cot then lowered an additional 6 inches.The manual release was used to raise the cot to allow the medics to remove their arms.The patient had not been loaded onto the cot at the time of incident and another service was called to complete the transport.The medics did seek medical intervention as a result of the incident and it was reported the medics received bruising to the forearms.The medics were off work for approximately 3 days and have since returned to their previous positions.An investigation will be initiated to evaluate the reported incident.
Additional Manufacturer Narrative
The device was evaluated by a field technician at the complainant's site.A visual and functional evaluation was conducted and it was observed both batteries in the power pac needed to be replaced.The batteries were replaced, the cot was serviced and then returned to service.Upon review of the evaluation and complaint details, it is determined the alleged injury to the medics is a probable result of not turning the main power switch off on the cot as instructed in the user manual prior to connecting the powerpac.Turning off the switch disables any input of the touch pads or com cable.No further information has been received alleging the patient was adversely affected by the delay in transport.
Event or Problem Description
It was reported while onsite for a non-emergency bariatric patient transport the cot would allegedly not work in power mode.The crew replaced the powerpac with an extra pac they had with them.While both medics were reaching under the cot to connect the new powerpac, the cot allegedly lowered approx 6 inches trapping their arms beneath the cot.It was also reported the cot then lowered an additional 6 inches.The manual release was used to raise the cot to allow the medics to remove their arms.The patient had not been loaded onto the cot at the time of incident and another service was called to complete the transport.The medics did seek medical intervention as a result of the incident and it was reported the medics received bruising to the forearms.The medics were off work for approximately 3 days and have since returned to their previous positions.An investigation will be initiated to evaluate the reported incident.

• Brand Name: POWERFLEXX
• Common Device Name: POWERFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6001049
• Report Number: 1523574-2016-00029
• Device Sequence Number: 13563109
• Product Code: FPO
• UDI-Device Identifier: 00190790000189
• UDI-Public: 00190790000189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/07/2016

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: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 12/07/2016
• 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