MAUDE Adverse Event Report: EKOS CORPORATION UNIVERSAL CART

Catalog Number 700-60101

Device Problem Mechanical Problem (1384)

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

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that an ekos cart was getting locked up and it was not functioning properly.There was no patient involved.The cart did not tip over in this event and no one was harmed.The cart is still under ekos warranty.The cart was returned to the contract manufacturer and a replacement cart was provided to the complainant.We are awaiting the investigation results of the cart from the contract manufacturer.A follow-up to this mdr will be provided once results of their evaluation are provided to ekos.

Event Description

It was reported that an ekos universal cart's wheels "had issues" and was getting locked up.It was inspected at the hospital by hospital personnel and reported to ekos to be not functioning properly.There was no patient involved.The cart did not tip over in this event and no one was harmed.

Manufacturer Narrative

It was reported that an ekos cart was getting locked up and it was not functioning properly.The cart is still under warranty.The cart was returned to the contract manufacturer and a replacement cart was provided to the complainant.The contract manufacturer investigated the returned cart condition, caster assembly and caster function.Their investigation could not confirm the issue of the wheels locking up.The casters performed as expected and no defect issues were noted.Since the reported condition of the cart wheels getting locked up could not be confirmed by the cart's contract manufacturer, a definitive root-cause could not be determined at this time.The cart did not tip over in this event and no one was harmed.

Event Description

It was reported that an ekos universal cart's wheels "had issues" and was getting locked up.It was inspected at the hospital by hospital personnel and reported to ekos to be not functioning properly.The cart did not tip over in this event and no one was harmed.

• Brand Name: UNIVERSAL CART
• Type of Device: UNIVERSAL CART
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: sharon gundersen ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254153100
• MDR Report Key: 6822593
• MDR Text Key: 83747309
• Report Number: 3001627457-2017-00025
• 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: Radiologic Technologist
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 700-60101
• Device Lot Number: 072816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1