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

Model Number	HORIZON-W
Medical Device Problem Codes	Poor Quality Image (1408); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after they were getting errors during a scan, causing the patient to be re-exposed.It was determined that the detector needed to be replaced.Once this was done the system is working as intended.

• Brand Name: HORIZON
• Common Device Name: DENSITOMETER, BONE
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 7052987
• Report Number: 1220984-2017-00207
• Device Sequence Number: 16160397
• Product Code: KGI
• UDI-Device Identifier: 15420045505834
• UDI-Public: 15420045505834
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Respiratory Therapist
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: Radiologic Technologist
• Device Model Number: HORIZON-W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1