MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2019

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 the ultra duo high fluid cart was parked in a evac room and it was tagged as leaking/do not use.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

It was reported in follow-up that the device was leaking from the bottom and manifolds were not extended.Hence upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• 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: 8615280
• MDR Text Key: 145223921
• Report Number: 0001954182-2019-00035
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K081047
• 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: 05/16/2019

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 Model Number: N/A
• Device Catalogue Number: ULDU500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1