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

Model Number 0015651

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported during the process of loading a pt into the ambulance the stretcher allegedly would not clear the hook.In an attempt to gain clearance, the emt attempted to slid the cot sideways while the other emt raised the legs of the cot and caught the other emt's finger in the pinch point of the leg.It is alleged the emt suffered a partial amputated finger.Initial conversation with the emt indicated no malfunction of the cot but rather operator error in grabbing the wrong part of the stretcher.The serial number of the stretcher has not been provided to date.

• Brand Name: POWERFLEXX POWERED COT
• Type of Device: POWER FLEXX POWERED COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; wilmington OH
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 4766624
• MDR Text Key: 21180953
• Report Number: 1523574-2015-00048
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2015

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: Health Professional
• Device Model Number: 0015651
• Device Catalogue Number: PT5600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/11/2015
• 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