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

Catalog Number ULDU500R

Device Problem Material Frayed (1262)

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

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

This complaint has been recorded by zimmer biomet under (b)(4).Udi no.(b)(4).On (b)(6) 2019, it was reported from (b)(6) hospital that a duo cart unit had some exposed wires.The previous repair record for intellicart system 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 record 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 one time, the previous repair being for the level sensor on 21 august 2018.The level sensor is not associated with the current repair.Thus, this repair was a non-related issue.Based on the complaint history review, there is no need for additional action as there is no lot number associated with this refurbished unit.On (b)(6) 2019, it was reported from (b)(6) hospital that a duo cart unit had some exposed wires.On 17 september 2019, pm medical was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that the power cord was damaged.He replaced the power cord and tested the unit to verify proper operation.He then returned the unit to service.Per crm, a repair checklist was not required.Service work order (b)(4) on 17 september 2019.Although the reported event of the unit having exposed wires was confirmed as the technician discovered the power cord was damaged, it is not known with the information available what caused the cord to fail.Therefore, based on the information provided, a specific root cause 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.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended for any adverse trends that may require additional actions.

Event Description

It was reported that the unit had some exposed wires.Event timing was pre-surgery.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• 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: 9140431
• MDR Text Key: 207033290
• Report Number: 0001954182-2019-00061
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1