MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART; APPARATUS, SUCTION, WARD USE, PORTABLE

Model Number N/A

Device Problem Unable to Obtain Readings (1516)

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

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Pma: k081047; k123188; k133786.The product will be evaluated by an external contractor.Once the evaluation/investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the cart did not register fluid on either cylinder.Event timing is unknown at this time.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The following sections have been updated.The previous repair report for ultra duo flex cart unit 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 once, the previous repair being for a spray head issue on (b)(6) 2016.The current reported was not related issue with spray head.So the previous and current repairs were not similar in nature.There was 07 complaints that contained part number: uldu500, lot# n/a and complaint description with ¿not register fluid¿.The highest occurrence for the given manufacture date was 01 complaint.The keyword of ¿not register fluid¿ was chosen as a filter based upon the reported failure of ¿the unit did not register fluid on either cylinder.¿ there was 07 complaints that contained part number: uldu500, complaint description with the keyword: ¿not register fluid¿ the keyword of ¿not register fluid¿ was chosen as a filter based upon the reported failure of ¿the unit did not register fluid on either cylinder.¿ on (b)(6) 2017, it was reported from mount nittany medical center that the unit was not registering fluid on both cylinder.The service company was contacted about the cart and dispatched a service technician to be at the site.On (b)(6) 2017, the technician found a multiple manifold filter in the cylinder; which causing the draining issue for the unit.So he removed the manifold filter from the cylinder and then he verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.Per crm, the repair checklist was not required.Product evaluated by external contractor.

• Brand Name: ULTRA DUO HIGH FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE
• 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: 7097525
• MDR Text Key: 94814787
• Report Number: 0001954182-2017-00038
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULDU500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2014
• 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