MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problems Crushing Injury (1797); Insufficient Information (4580)

Event Date 10/14/2021

Event Type  Death  

Manufacturer Narrative

Age at time of event: 60s.There are no additional device identification numbers.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 a patient was being scanned, and due to his critical condition, needed to stay on oxygen during his scan.The patient was connected to an oxygen tank that weighed more than 10kg and placed approximately 2m away.The oxygen tank and cart were attracted to, and entered the magnet bore, striking the patient inside.The patient expired.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.Based on the information provided, the incident occurred due to lack of controlled access.The mr technical staff failed to limit and monitor access to the magnet room which allowed an untrained member of the hospital staff to bring a ferrous oxygen tank and cart into the scan room.The mr safety guide or the operator manual with integrated safety section, which has been delivered to the customer, clearly defines the risks associated with owning and operating an mr scanner.It was confirmed that the ferrous object warning signs were present at the site.The customer successfully activated the magnet run down unit (mru) which ramped down the magnet and they removed the oxygen tank, cart, and patient from the scanner.No further actions are planned by gehc.

• Brand Name: GE 1.5T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 12739907
• MDR Text Key: 279680874
• Report Number: 2183553-2021-00012
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K052293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male