MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULDU500

Device Problem Incorrect Measurement (1383)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This investigation is being completed per as no problem was found.Therefore, the complaint history and dhr reviews are not required.On (b)(6) 2018 it was reported from (b)(6) that the unit was not reading the correct volume.On (b)(6) 2018, (b)(4) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and was unable to confirm that the unit was reading the volume incorrectly.The technician verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.Service work order (b)(4) on (b)(6) 2018.The root cause for the reported volume issue could not be determined as the technician was unable to replicate the reported event.The technician inspected the device and noted that it was functioning as intended.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the unit was not reading correct volume amount.The event occurred during prior to surgery.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8210255
• MDR Text Key: 131923832
• Report Number: 0001954182-2019-00002
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1