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 Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the cart was giving off a burning smell.The valve pack needed to be replaced.The event occurred before surgery.The event was not identified immediately upon the receipt (before use) of a recently purchased or serviced/repaired device.

Manufacturer Narrative

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

Event Description

No additional information.

• 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: 8371671
• MDR Text Key: 137848983
• Report Number: 0001954182-2019-00019
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• 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: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1