MAUDE Adverse Event Report: ANDREAS HETTICH GMBH & CO. KG HETTICH EBA 280S TABLETOP CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Model Number EBA 280S

Device Problems Difficult to Open or Close (2921); Incomplete or Inadequate Connection (4037)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Defect with hettich eba 280 / 280s tabletop centrifuge lid latch assemblies.There is a failure in which a small gear in the lid latch assembly will slide off of the rod such that it no longer makes contact with the other gear as intended.This results in the lid not opening and a lid lock error.Staff then have to use a hex wrench to manually open the lid to retrieve patient samples.The remedy for the lid error per the operator's manual does not resolve the malfunction.The replacement lid latch assembly from ozark biomedical has a tac weld on the gear to prevent this failure.Affected units include serial numbers: (b)(4).Acquisition dates between 2019-2020.

• Brand Name: HETTICH EBA 280S TABLETOP CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): ANDREAS HETTICH GMBH & CO. KG
• MDR Report Key: 16337116
• MDR Text Key: 309403291
• Report Number: MW5114805
• Device Sequence Number: 7
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/06/2023
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EBA 280S
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1