MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; WASHER OF BODY WASTE RECEPTACLES

Catalog Number ULDU500

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Duo fluid cart unit was not reading fluid appropriately.The event timing was unknown.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

On 09 january 2018, it was reported from (b)(6) medical center that the unit is not reading fluid appropriately.On 09 january 2018, adams cooper plumbing 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 the reported event and noted no defects with the unit.The technician then verified that the unit was functioning as intended and returned the unit to service without further incident.The reported event was never confirmed during inspection of the device and the device was noted to be functioning as intended.Therefore, the root cause could not 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

No additional information received.

• Brand Name: DUO FLUID CART
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8261073
• MDR Text Key: 134097553
• Report Number: 0001954182-2019-00006
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• PMA/PMN Number: K123188
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1