MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CENTRIFUGE US (REFURBISHED)

Model Number	ANGEL CENTRIFUGE US (REFURBISHED)
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, a sales representative reported via (b)(4) that an abs-10060r angel centrifuge us (refurbished) had a "disk boot failure." no patient was harmed, and they were able to run another angel machine quickly to complete the case.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged abs-10060r serial/batch number (b)(6) was received for investigation.Functional testing was performed connecting the device to the power; when the on button was pressed, a failure error was noted on the screen: disk boot failure; disk boot failure is typically caused by a hardware memory system failure in the console's sbc operating system.It manifests typically on older machines and usually only when powering up.Visual inspection revealed signs of wear and tear.The most likely reason for the reported failure is wear and tear on the device, as the manufacturing date is 13 november 2018.

• Brand Name: ANGEL CENTRIFUGE US (REFURBISHED)
• Common Device Name: CENTRIFUGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20633185
• Report Number: 1220246-2024-08457
• Device Sequence Number: 7404224
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: 00888867249585
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: ANGEL CENTRIFUGE US (REFURBISHED)
• Device Catalogue Number: ABS-10060R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown