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 Problems Melted (1385); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On (b)(6) 2019, it was reported from (b)(6) medical center that a duo cart unit was smoking.Per followup, the unit had a melted power inlet module.On (b)(6) 2019, (b)(4) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and found that the power inlet module of the unit had failed and melted.The technician replaced the power inlet module (part #90204) and then 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 as per cl ¿ repair cart and evac rev.0.Service work order (b)(4) on (b)(6) 2019.Although the reported event of the unit smoking and the power inlet module melting was confirmed during inspection of the device, and the device was noted to be functioning as intended after the power inlet module was replaced, it is not known with the information available what caused the power inlet module to melt to begin with.Therefore, based on the information provided, the specific root cause of the reported event cannot be determined.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 power inlet module melted.The power inlet was replaced and returned to service.The event occurred before surgery.No adverse events were reported as a result of this malfunction.No additional event information available.

• 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: 8561626
• MDR Text Key: 143445409
• Report Number: 0001954182-2019-00029
• 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: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/09/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1