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

Model Number 0015654

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported a bolt was allegedly missing from the drop frame of the device.No patient involvement or injuries were reported with this incident.

Manufacturer Narrative

A visual and functional evaluation was conducted by ferno's authorized field service representative.The complaint was confirmed.This complaint resulted from an observation and no incident occurred as a result of the missing hardware.The device was repaired, tested and returned to service.The cot was 1 year old at the time of complaint and the actual cause of the missing hardware is unknown.

• Brand Name: POWERFLEXX POWERED COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; wilmington OH
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 4751574
• MDR Text Key: 5768122
• Report Number: 1523574-2015-00045
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0015654
• Device Catalogue Number: PT5600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 04/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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