MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC DIMENSIONS MAMMOGRAPHY UNIT IN A MATHEWS COACH.; FULL FIELD DIGITAL, SYSTEM, X-RAY MAMOGRAPHIC.

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2019

Event Type  malfunction  

Event Description

(b)(6) health system: mobile coach evaluation report dimensions s/n (b)(4).Date when coach was put into use: (b)(6) 2018.Coach vendor: mathews specialty vehicles (b)(4).Problem: on saturday (b)(6) at 9:45 am mobile coach was traveling in (b)(6) when the driver heard a loud crash from inside the coach mammo room.Upon inspection the dimensions gantry had separated rom the floor and had fallen over and is now multiple pieces.No personnel were in the mammography room during transit-- all are in standard seats with seat belts.No patients were on the coach ( or are ever on the coach) during transit.Thus, no harm- other than missed appointments occurred- to patients or staff.We consider this a near miss.Investigation by hologic team led by (b)(4) is as follows: "the rear main baseplate bolts (location 1 and 2) were 2-inch wood screws that were ripped from the floor.These wood screws never penetrated thru the floor to the undercarriage.This weak attachment caused the rear baseplate to rock forward during travel.There is also a visible gap between the rear of the baseplate and the floor indicating that it has bent over time due to back and forth motion.It was discovered that all 10 hex bolts attaching the gantry body to the baseplate had worked loose over time, most likely caused by a loose baseplate motion during travel.Further inspection of these hex bolts believed to have come from locations 10 and 11.Inspection of the undercarriage showed that the main front baseplate bolts (locations 6 and 8) were acceptable lag bolts that had penetrated the coach floor and were attached to the undercarriage and intact, however the undercarriage was not strengthened with an additional metal plate.Connection of the two main front baseplate bolts location 6 and 8 seemed to be attached to soft underside of coach floor and not to hard chassis metal.Next to location 6 bolt was an empty hold indicating that the gantry was relocated at one time." mathew's specialty vehicles now has the mobile in (b)(4) for evaluation/repair.All bolts have been collected, tagged and will be sent to hologic for evaluation.Fda safety report id # (b)(4).

• Brand Name: HOLOGIC DIMENSIONS MAMMOGRAPHY UNIT IN A MATHEWS COACH.
• Type of Device: FULL FIELD DIGITAL, SYSTEM, X-RAY MAMOGRAPHIC.
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 9249760
• MDR Text Key: 164585063
• Report Number: MW5090733
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other