MAUDE Adverse Event Report: RELIGN CORPORATION DUO FLUID CART - REFURBISHED

Catalog Number UE514010100

Device Problems Melted (1385); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined unit had no power.Power inlet module/fuse were burnt/melted.Power inlet module was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that outside of surgery that the unit has no power.After evaluation it was determined that the power inlet module and fuse were burnt/melted.There was no harm or injury to the patient as there was no patient involvement.Due diligence complete.No additional information is available.No adverse event reported.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Upon reassessment of the reported event, it was determined this mdr was not filed under the current mfr number.This event will be reported on mfr - 0001526350 - 2023 - 00975.

Event Description

Upon reassessment of the reported event, it was determined this mdr was not filed under the current mfr number.This event will be reported on mfr - 0001526350 - 2023 - 00975.

• Brand Name: DUO FLUID CART - REFURBISHED
• Type of Device: DUO FLUID CART
• Manufacturer (Section D): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer (Section G): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17611280
• MDR Text Key: 321827917
• Report Number: 3012790575-2023-00004
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024466029
• UDI-Public: (01)00889024466029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose