MAUDE Adverse Event Report: EKOS CORPORATION UNIVERSAL CART; STAND, INFUSION, PRODUCT CODE: FOX

Catalog Number 700-60101

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

The nurse attempted to hold the cart as it was falling and twisted her knew.The complainant reported that the wheels locked up during the transport.The hospital biomed discarded the cart.Therefore no additional investigation could be performed.Review of internal records indicate that the product was manufactured in 2013 and out of warranty.Ekos field personnel were unable to obtain additional follow up information.Ekos was informed that no other intervention was required.Should information become available, a follow up mdr will be submitted.

Event Description

A biomed tech reported that wheels on the ekos cart seemed to have locked up during transport and the cart tipped over.It fell on the nurse who was moving the cart.There was no patient involved.The nurse twisted her knee when attempted to catch the falling cart.Employee health reviewed the incidence and provided a bandage.No surgical intervention or other follow up required.

• Brand Name: UNIVERSAL CART
• Type of Device: STAND, INFUSION, PRODUCT CODE: FOX
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek pkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORP; 11911 north creek pkway s; bothell WA 98011
• Manufacturer Contact: mani shanmugham ; 11911 north creek pkway s; bothell, WA 98011 ; 4254891279
• MDR Report Key: 6701419
• MDR Text Key: 79969467
• Report Number: 3001627457-2017-00020
• Device Sequence Number: 1
• Product Code: FOX
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2017

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?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 700-60101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1