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 Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that an ultra duo high fluid cart non-sterile had a frayed power cord.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair report for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 3 times, the previous repair being for a foreign object on may 7, 2019.This is not associated with the current repair.Thus, this repair was a non- related issue.On aug 26, 2019, it was reported from (b)(6) hospital that the unit had a concern with the carts power cord.A zimmer biomet authorized service technician was contacted and dispatched to be at the site.Upon investigation, the technician verified the power cord had damage by the plug to the wall.He replaced the power cord (part# 91822).Tested all functions and returned the cart to service.He also replaced the cart skirt mount kit (part# 70022; lot code 0025302).The device was tested, inspected, and repaired as per cl ¿ repair carts and evac.Service work order (b)(4) on aug 26, 2019.While the service technician confirmed the reported event and the device was noted to be functioning as intended after the power cord was replaced, it is unknown with the information provided why the power cord was damaged.Therefore, based on the information provided, a 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.

• 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
• MDR Report Key: 8939085
• MDR Text Key: 194610290
• Report Number: 0001954182-2019-00052
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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
• Device Lot Number: 0016244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1