MAUDE Adverse Event Report: HOLOGIC, INC MULTICARE PLATINUM; STEREOTACTIC BREAST BIOPSY SYSTEM

Model Number	8-004-0017
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that for a multicare platinum , the equipment would not start and would smell like burned.On december 29th a field engineer examined the console and determined that the issue occurred during the startup of the system and that there were no patients during the problem.The customer reported at that point that when they started the computer they observed a small fire coming from the dsm and immediately activated the safety device which unplugged everything.The engineer on site confirmed that the problem came from the transformer.No injury was reported to staff or patient.The parts damaged will be replaced.No other information is available.

• Brand Name: MULTICARE PLATINUM
• Common Device Name: STEREOTACTIC BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 16236807
• Report Number: 1220984-2023-00008
• Device Sequence Number: 6992728
• Product Code: IZH
• UDI-Device Identifier: 15420045505926
• UDI-Public: 15420045505926
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K030666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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: 8-004-0017
• Device Catalogue Number: 8-004-0017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown