MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Fluid/Blood Leak (1250); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation and evaluation of the device is in process.Once the investigation is completed, a supplemental report will be filed.

Event Description

T was reported that the unit would not turn on when plugged in.There was no harm to the patient.Cfu: before surgery the tech saw the power cord and power inlet were damaged.The tech found leaking under cylinder #2.There was burning to the power cord and partial melting of the power inlet.No frayed or exposed wires.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4 - udi# - (b)(4).Product evaluation: product review of the duo fluid cart serial number 1170639 by zimmer biomet certified service repair technician on may 07, 2020 revealed that the power cord had signs of burning close to the power inlet, and the power inlet itself was partially melted.There was a leak underneath cylinder 2.There was no evidence of pooled fluid and the insulation was not wet.Per crm, checklist was not required.Product repair: repair of the device was performed by repair site/zimmer biomet certified service repair technician on may 07, 2020 which included replacement of the following: power cord and power inlet module cart; serial# 1570081 was put back to service.The device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

There is no additional information.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 10051363
• MDR Text Key: 190777117
• Report Number: 0001954182-2020-00021
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• 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: 00514010100
• Device Lot Number: 0025730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1