MAUDE Adverse Event Report: HOLOGIC, INC. FLUOROSCAN PREMIER; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

Bolt that holds c-arm in place while transporting was sheared off.Cause of this was design of stabilizer.Will potentially shear off again.No serious patient care issue, however device could be damage due to c-arm not stable during transport.

• Brand Name: FLUOROSCAN PREMIER
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): HOLOGIC, INC.; 35 crosby dr.; bedford MA 01730
• MDR Report Key: 5996557
• MDR Text Key: 56372108
• Report Number: 5996557
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2016

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1