MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 00514010100

Device Problem Output Problem (3005)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the unit both cylinders were not reading correct volume during case.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

On 08 nov 2018, it was reported from (b)(6) medical center that a cart was not reading the correct volume on both cylinders.On 08 nov 2018, replite was contacted about the unit and dispatched a service technician to be at the site.The technician arrived at the site on 27 nov 2018 and was not able to reproduce the reported event or find any other issues with the device.The technician verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 08 nov 2018.The root cause of the reported event cannot be specifically determined with the provided information because the service technician was not able to reproduce the reported event or find any other issues with the device.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional information received.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8062531
• MDR Text Key: 127871544
• Report Number: 0001954182-2018-00070
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010100
• Device Lot Number: 0028014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1