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

Model Number 0015617

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that during a patient transfer the cot allegedly lowered unexpectedly.It is alleged the patient was injured but details of the alleged injury were not provided.The complainant stated the incident was "probably crew error" and was requesting an evaluation only.

Manufacturer Narrative

The device was evaluated by ferno's authorized field service representative at the customer's location.A visual/functional evaluation was conducted.The alleged incident could not be confirmed; however, multiple observations of lack of maintenance were noted.The customer authorized the repair and cleaning of those observations and the cot was returned to service.The cot was almost 12 yrs old at the time of incident and evaluation.A review of the serial number revealed no related prior complaints and service records indicate the cot had not received a pm service since (b)(6) 2013.No additional information was provided regarding the report of an alleged patient injury or details of the incident and how "operator error" may have been a factor.

• Brand Name: !!35P PROFLEXX X FRAME COT
• Type of Device: !!35P PROFLEXX X FRAME COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh 45177 OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh 45177 OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 4950683
• MDR Text Key: 16156439
• Report Number: 1523574-2015-00072
• 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: Consumer,Health Professional,consumer,health profess
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 09/05/2015

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
• Device Operator: Emergency Medical Technician
• Device Model Number: 0015617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2003
• 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