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

Model Number N/A

Device Problems Device Emits Odor (1425); Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).(b(4), pma#.K081047; k123188; k133786.The reported event was confirmed by the service technician who performed the repair as per cl-install carts.Md biomedics was contacted about cart and dispatched a service technician to be at the site.The service technician arrived at the site and inspected the device.He found that the valve pack control board had overheated.He replaced the valve pack, but then found that the device was leaking due to a cracked bottom plate.An exchange was then scheduled for the device.A new cart was shipped from riverside to the facility.The new cart was confirmed to have been delivered to the hospital and the service technician was dispatched to the site to perform the exchange.The technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The device was tested and inspected.The technician then repackaged the cart so that it could be returned to riverside.The exchanged cart was picked up from the facility later that day and was confirmed to have been returned to riverside.The root cause of the cart producing a burning smell could not be specifically determined with the provided information.The issue was resolved with an exchange.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that there was a burning smell and did not power up.No adverse events have been reported as a result of the malfunction.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
• 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: 6765060
• MDR Text Key: 81846029
• Report Number: 0001954182-2017-00010
• 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
• Report Date: 08/03/2017

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: ULDU500SE
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1