MAUDE Adverse Event Report: EKOS CORPORATION UNIVERSAL CART FOR THE EKOSONIC ENDOVASCULAR CATHETER

Catalog Number 700-60201

Device Problems Failure To Run On AC/DC (1001); Failure to Charge (1085)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported on (b)(6) 2017 that two control units for a bilateral pulmonary embolism case would not turn on.During troubleshooting steps on the phone with an ekos helpline representative, it was determined that two ekos control units were plugged into one battery.The ekos representative directed the user to plug the two ekos control units directly into a wall power outlet and they successfully turned on.The warranties for the two (b)(6) at this hospital expired on (b)(6) 2015.Once the control units were connected to an electrical supply, they functioned normally.The instructions for use contain the following statements: keep the battery plugged in at all times, except during mobile use, to keep the battery fully charged.The cart is intended for use with an ekos control unit.Do not connect any other devices to the battery.On the back of the ups, there is a label stated "do not use" on the second outlet.We are filling this mdr in response to the user facility's medwatch report #(b)(4) that we received from the fda on 8/31/2017.The user stated that therapy was initiated for the patient after they successfully plugged in the control units and the patient is doing "fine." there was no follow-up calls or reports from the user of a device malfunction or an adverse patient impact.

Event Description

It was reported to ekos on (b)(6) 2017 that two control units for a bilateral pulmonary embolism case would not turn on.During troubleshooting steps on the phone with an ekos helpline representative, it was determined that two ekos control units were plugged into one uninterruptible power supply (ups).The ekos representative directed the user to plug the two ekos control units directly into a wall power outlet and they successfully turned on.The user reported the patient is doing "fine.".

Manufacturer Narrative

It was reported on (b)(6) 2017 that two control units for a bilateral pulmonary embolism case would not turn on.During troubleshooting steps on the phone with an ekos helpline representative, it was determined that two ekos control units were plugged into one battery.The ekos representative directed the user to plug the two ekos control units directly into a wall power outlet and they successfully turned on.The warranties for the two upss at this hospital expired on 6/26/2015.Once the control units were connected to an electrical supply, they functioned normally.The instructions for use contain the following statements: keep the battery plugged in at all times, except during mobile use, to keep the battery fully charged.The cart is intended for use with an ekos control unit.Do not connect any other devices to the battery.On the back of the ups, there is a label stated "do not use" on the second outlet.We are filling this mdr in response to the user facility's medwatch report #(b)(4) that we received from the fda on 8/31/2017.The user stated that therapy was initiated for the patient after they successfully plugged in the control units and the patient is doing "fine." there was no follow-up calls or reports from the user of a device malfunction or an adverse patient impact.Follow-up submitted to correct "date of this report" value.

Event Description

It was reported to ekos on (b)(6) 2017 that two control units for a bilateral pulmonary embolism case would not turn on.During troubleshooting steps on the phone with an ekos helpline representative, it was determined that two ekos control units were plugged into one uninterruptable power supply (ups).The ekos representative directed the user to plug the two ekos control units directly into a wall power outlet and they successfully turned on.The user reported the patient is doing "fine.".

• Brand Name: UNIVERSAL CART FOR THE EKOSONIC ENDOVASCULAR CATHETER
• 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: 6856689
• MDR Text Key: 85805509
• Report Number: 3001627457-2017-00028
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 700-60201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 63 YR