MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION OPTIMA CT660; SYSTEM,X-RAY,TOMOGRAPHY,COMPUTED

Model Number CSPG52

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be provided after the investigation has been completed.Unique identifier: udi not required.Legal manufacturer: (b)(4).

Event Description

It was reported that a patient sustained a broken wrist when the table moved out of the bore after a head scan.

Manufacturer Narrative

It was reported that when a coma patient was being scanned, their arm suddenly fell off the table while it was traveling out of the gantry bore.Contacting the gantry, the left wrist joint sustained a fracture.The system has been certified for iec60601-1.The cradle movement is controlled by a control panel on the gantry or a foot pedals on the table.The operation is by continuous activation as specified.The gantry has a collision sensor which detects a touch by objects at the top center of the bore.Three types of patient straps (50mm, 100mm and 320mm wide) are provided as accessories with the system.The gantry and the operator's console has emergency switches so that the operator can stop any movement/scan.The technical reference manual and user manual require the customer to secure and position the patient properly during a scan.Root cause was determined to be a patient positioning error.A patient strap was used for the body but arms were not secured since the operator did not anticipate patient arm motion since the patient was in a coma.Risk analysis has concluded the residual risk of this design has been reduced to afap.Ge will continue to trend similar events.No further action is planned.

• Brand Name: OPTIMA CT660
• Type of Device: SYSTEM,X-RAY,TOMOGRAPHY,COMPUTED
• Manufacturer (Section D): GE HEALTHCARE JAPAN CORPORATION; 7-127 asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• MDR Report Key: 9527324
• MDR Text Key: 188560047
• Report Number: 9612283-2019-00003
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K110227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSPG52
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention