MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUO FLUID CART WITH POWER IV, REFURBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number	N/A
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is complete and this event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the cart was not powering on and the power inlet module showed signs of heat damaged and was replaced, but did not resolve the issue, so the power supply was replaced, which did not resolve the issue, so the control board was replaced and the cart would still not power on, so the power supply was replaced again and resolved the issue.It is unclear if the control board had an issue that took out the first new power supply.The cart wiring kit was also replaced and resolved the reported issue.Review of the previous repair record identified unrelated repairs to the reported event.The device was tested and found to be functioning to specifications prior to release to the customer.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 or Problem Description
It was reported that the cart would not power on and the inlet module showed signs of heat damage.No adverse events were reported as a result of this malfunction.

• Brand Name: DUO FLUID CART WITH POWER IV, REFURBISHED
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 12145690
• Report Number: 0001526350-2021-00777
• Device Sequence Number: 3989025
• Product Code: JCX
• UDI-Device Identifier: 00889024501645
• UDI-Public: (01)00889024501645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UE514010300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1