MAUDE Adverse Event Report: HOLOGIC, INC. HORIZON; DENSITOMETER, BONE

Model Number	HORIZON-A
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after scan the file failed to open, causing the patient to be re-exposed.Restarting the system resolve the issue.

• Brand Name: HORIZON
• Common Device Name: DENSITOMETER, BONE
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 7006817
• Report Number: 1220984-2017-00135
• Device Sequence Number: 11080871
• Product Code: KGI
• UDI-Device Identifier: 15420045505384
• UDI-Public: 15420045505384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: KO23398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 10/09/2017

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: Service Personnel
• Device Model Number: HORIZON-A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1