MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO ECHO V2.0; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0087000R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2023 an immucor field service engineer (fse) examined galileo echo v2.0 instrument serial number (b)(6) at the customer site.The fluidics module lid lock was determined to be worn/damaged and was replaced.The internal immucor reference for this event is (b)(4).
Event or Problem Description
On (b)(6), 2023 a customer reported that an operator received a minor injury when the opened fluidics cover on their galileo echo v2.0 instrument unexpectanly fell down during the decontamination process.

• Brand Name: GALILEO ECHO V2.0
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 17558805
• Report Number: 1034569-2023-00023
• Device Sequence Number: 19739601
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: BK170132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0087000R
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female