MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X PROFLEXX X FRAME COT

Model Number 0015703

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

Patient Problems Pain (1994); Numbness (2415)

Event Date 07/19/2016

Event Type  No Answer Provided  

Event Description

It was reported the customer contacted a field technician for evaluation and inspection of a cot due to an alleged failure.Upon arriving onsite the technician was made aware the cot was involved in an incident occurring during a patient transport and allegedly involved potential injury to a patient and medic.The technician reported the incident to the manufacturer and the customer was contacted to gather more information on the allegations.The customer stated while unloading a patient from the truck the drop frame on the cot allegedly came loose and the cot tilted.The medic assumed the weight of the cot to keep the cot from dropping the patient.The medic and patient were seen at the hospital.The patient is alleging knee pain but no further details have been reported to the medic service.The attending medic was seen for back pain and leg numbness.The medic did miss work due to the alleged injury and is awaiting instruction from his doctor as to when he can return to work.The field technician did observe missing and loose hardware on the cot and replaced such hardware.The cot is remaining out of service until the conclusion of the investigation of the reported incident.

Manufacturer Narrative

The cot was evaluated at the complainant's location on 7/21/2016.A visual and functional evaluation was conducted.It was confirmed the drop frame assembly was no longer attached on the patients left side.The drop frame bolt and washer was missing.Other missing or loose hardware surrounding the drop frame zone was also observed.It could not be determined how or when the bolt became detached from the cot.The complainant authorized repairs on all of the observed hardware issues and all repairs were made.The user manual for the product does recommend regular inspections of the device to ensure all hardware is securely in place.No additional information has been provided regarding the alleged injury to the medic or patient.

Event Description

It was reported the customer contacted a field technician for evaluation and inspection of a cot due to an alleged failure.Upon arriving onsite the technician was made aware the cot was involved in an incident occurring during a patient transport and allegedly involved potential injury to a patient and medic.The technician reported the incident to the manufacture and the customer was contacted to gather more information on the allegations.The customer stated while unloading a patient from the truck the drop frame on the cot allegedly came loose and the cot tilted.The medic assumed the weight of the cot to keep the cot from dropping the patient.The medic and patient were seen at the hospital.The patient is alleging knee pain but no further details have been reported to the medic service.The attending medic was seen for back pain and leg numbness.The medic did miss work due to the alleged injury and is awaiting instruction from his doctor as to when he can return to work.The field technician did observe missing and loose hardware on the cot and replaced such hardware.The cot is remaining out of service until the conclusion of the investigation of the reported incident.

• Brand Name: 35X PROFLEXX X FRAME COT
• Type of Device: 35X PROFLEXX X FRAME COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 5820594
• MDR Text Key: 50391130
• Report Number: 1523574-2016-00021
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015703
• Device Catalogue Number: 0015710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR