MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. IN/X POWERED COT

Model Number	0015802
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/30/2017
Type of Reportable Event	Death
Event or Problem Description
It was reported medics were called to a residence for a non-responsive female.When the medics attempted to unload the stretcher from the ambulance to transport the patient to the hospital the power mode would allegedly not operate due to dead batteries.The crew did not attempt to use the manual mode but rather called a secondary unit to complete the transfer.Complainant advised the delay did not hinder their ability to care for the patient and did not affect the outcome of the patient as she was already in full cardiac arrest and beyond resuscitation upon their arrival to the scene.Upon arrival to the hospital the patient was declared deceased.The cot was removed from service and the company mechanic verified the ics charging system in the ambulance was working correctly.This incident will be investigated and the batteries involved will be evaluated.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted by an authorized field technician at the customer's location.It was observed the charging accessory in the ambulance was sitting too high and was not making a full connection with the contact points on the cot.The charging system was adjusted downward to ensure full contact was made between the charging system and the cot.The cot was also evaluated and passed all inspection points including the operation of the manual release.The cot is equipped with a manual mode to allow continued function of the cot if the power fails.The adjustment of the charging system is a component that needs to be inspected on a regular basis due to its constant interaction with loading and unloading the cot.Instructions to adjust, maintain and troubleshoot the charging system is provided in the user manual.
Event or Problem Description
It was reported medics were called to a residence for a non-responsive female.When the medics attempted to unload the stretcher from the ambulance to transport the patient to the hospital the power mode would allegedly not operate due to dead batteries.The crew did not attempt to use the manual mode but rather called a secondary unit to complete the transfer.Complainant advised the delay did not hinder their ability to care for the patient and did not affect the outcome of the patient as she was already in full cardiac arrest and beyond resuscitation upon their arrival to the scene.Upon arrival to the hospital the patient was declared deceased.The cot was removed from service and the company mechanic verified the ics charging system in the ambulance was working correctly.This incident will be investigated and the batteries involved will be evaluated.

• Brand Name: IN/X POWERED COT
• Common Device Name: IN/X POWERED COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6294352
• Report Number: 1523574-2017-00005
• Device Sequence Number: 737045
• Product Code: FPO
• UDI-Device Identifier: 00190790000011
• UDI-Public: 00190790000011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/26/2017

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: 0015802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 05/26/2017
• 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: Death
• Patient Age: 19 YR