MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING DISCOVERY 670; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number NMH950

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Head Injury (1879)

Event Date 06/27/2023

Event Type  Death  

Manufacturer Narrative

Udi not required.Legal manufacturer: hcs haifa fi - 4 hayozma st.Israel tirat hacarmel hefa, 30200.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

While a field engineer was servicing the device table, the engineer removed a component which caused the top of the table to fall.It struck the engineer on the head, and they were taken to the er at the hospital where the engineer was pronounced dead.The investigation is ongoing.

Manufacturer Narrative

A ge healthcare (gehc) field service engineer (fse) was performing maintenance on a nm/ct 670 table.The fse was seriously injured and fell unconscious when the table dropped and struck him in the head.He died due to these injuries later that day.Nm/ct670 table service instructions: nm/ct670 table has two red safety stoppers under the table.Safety stoppers are placed in a stored position when the table is in clinical use.When the table is being serviced, safety stoppers must be moved to their maintenance쳌 position to prevent the table from dropping.Gehc service manual instructs fses to move the safety stoppers from their stored쳌 position to their maintenance쳌 position prior to conducting any under-table servicing.When placed in maintenance쳌 position, the safety stoppers are effective in preventing the table from dropping.In addition, the manual instructs that table side covers need to be removed prior to service under the table, which allows and fse to perform maintenance without having to place their head or upper torso under the table.A warning label is also affixed to the component being serviced which states warning.Danger of injury or damage to equipment.The screws covered by this label may be opened by service personnel only.Ensure that the table elevation mechanism is locked before opening the screws.쳌 fses are trained on these steps prior to servicing gehc nm/ct 670 tables.

• Brand Name: DISCOVERY 670
• Type of Device: SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• Manufacturer (Section G): GE MEDICAL SYSTEMS ISRAEL; functional imaging; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 17404591
• MDR Text Key: 319838439
• Report Number: 9613299-2023-00009
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: NMH950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male