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

Model Number 0015710

Device Problems Device Tipped Over (2589); Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)

Event Date 12/11/2015

Event Type  Injury  

Event Description

It was reported that during the transport of a patient from their house to the ambulance, the stretcher was rolled over uneven pavement and tipped over with the patient.The patient made contact with the ground.And allegedly sustained a broken nose and a broken c1,c2.Medical intervention was necessary as a result of the incident.There has been no allegation of a cot malfunction; however, an investigation has been initiated and the stretcher will be returned to ferno for evaluation.

Manufacturer Narrative

The cot was returned to manufacturer for visual and functional evaluation.There were a couple of maintenance issues observed but nothing that affected the control of the side to side movement of the cot.All four wheels rolled freely and swiveled properly.The cot functioned as intended and there was no evidence of any component failure that would affect the safety of the patient or end user.The customer was contacted for follow up on the patient's reported injuries and they had no new information to provide.

Event Description

It was reported that during the transport of a patient from their house to the ambulance, the stretcher was rolled over uneven pavement and tipped over with the patient.The patient made contact with the ground.And allegedly sustained a broken nose and a broken c1,c2.Medical intervention was necessary as a result of the incident.There has been no allegation of a cot malfunction; however, an investigation has been initiated and the stretcher will be returned to ferno for evaluation.

• 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: 5348180
• MDR Text Key: 35192072
• Report Number: 1523574-2016-00001
• 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: health professional
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015710
• Device Catalogue Number: PT3570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR