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

Model Number 0015654

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was alleged that a bolt was missing from the stretcher's drop frame.No pt involvement was reported.

• Brand Name: POWERFLEXX POWERED COT
• Type of Device: 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: 4635371
• MDR Text Key: 5617375
• Report Number: 1523574-2015-00016
• 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: Other
• Type of Report: Initial
• Report Date: 03/19/2015

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: Not provided
• Initial Date FDA Received: 03/19/2015
• 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