MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC NUCLEAR MAGNETIC RESONANCE IMAGING; SIGNA ARTIST

Device Problems Detachment of Device or Device Component (2907); Installation-Related Problem (2965); Device Fell (4014)

Patient Problems Death (1802); Injury (2348)

Event Date 10/31/2018

Event Type  Death  

Manufacturer Narrative

There are no additional device identification numbers.Unique identifier: udi not yet assigned.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that while a magnet was being lifted by a crane for device installation, the magnet became detached from the crane, fell over and crushed a third-party logistics contractor.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.Due to limited information provided by the customer, it is inconclusive as to the root cause of the event.It has been concluded, however, that gehc is not at fault.Gehc reviewed the contractual agreements and determined that safe magnet handling and installation was the responsibility of the rigging company.Magnet delivery, which includes unloading, movement to the mr suite, leveling and bolting the magnet in place, are the responsibilities of the rigging company and not gehc.

• Brand Name: NUCLEAR MAGNETIC RESONANCE IMAGING
• Type of Device: SIGNA ARTIST
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 8117181
• MDR Text Key: 128809154
• Report Number: 2183553-2018-00018
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K163331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 51 YR