HORIZON HORIZON-W N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-28 for HORIZON HORIZON-W N/A manufactured by Hologic, Inc..

Event Text Entries

[96009572] It was reported that after they were getting errors during a scan, causing the patient to be re-exposed. It was determined that recalibration of the filter drum and aperture were needed as well as adjusting the gain. Once this was done, the system is working as intended.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220984-2017-00295
• MDR Report Key: 7152115
• Report Source: USER FACILITY
• Date Received: 2017-12-28
• Date of Report: 2017-11-29
• Date of Event: 2017-11-29
• Date Mfgr Received: 2017-11-29
• Device Manufacturer Date: 2017-09-25
• Date Added to Maude: 2017-12-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RESPIRATORY THERAPIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DEBRA ROSENBERG
• Manufacturer Street: 36 & 37 APPLE RIDGE ROAD
• Manufacturer City: DANBURY CT 06810
• Manufacturer Country: US
• Manufacturer Postal: 06810
• Manufacturer Phone: 2032074512
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HORIZON
• Generic Name: DENSITOMETER, BONE
• Product Code: KGI
• Date Received: 2017-12-28
• Model Number: HORIZON-W
• Catalog Number: N/A
• Lot Number: N/A
• Operator: RADIOLOGIC TECHNOLOGIST
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOLOGIC, INC.
• Manufacturer Address: 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-12-28