MAUDE Adverse Event Report: SIEMENS DEFINITION FLASH; CT SCANNER

Device Problems Protective Measures Problem (3015); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

A (b)(6) baby with congenital heart disease was scanned on a flash scanner using a gated flash mode (fast pitch mode).The baby was connected with ecmo.During the scan, the patient table moved extremely quickly over a long range and introduced a lot of tension to the ecmo tubing.There was a real chance it could have pulled the tubing out of the baby and caused it to bleed to death almost instantly.Thankfully it didn't happen, but it really scared everyone.Different from a regular helical ct scan, the patient table in the flash scan mode travels a long distance beyond each end of the prescribed scan range, which is needed for acceleration and deceleration of the table to a fast speed.However, there is no warning before the flash scan showing the ct operator that the patient table would move far away from the prescribed scan range (more than 30 cm on each end).Because of the lack of warning, the ct operator has no chance to see of test exactly how far the table would move and whether the connected tube/wires are safe during the scan.If the patient is connected to any kind of life support devices, the rapid table movement over a long range without warning could be a serious safety risk.

• Brand Name: DEFINITION FLASH
• Type of Device: CT SCANNER
• Manufacturer (Section D): SIEMENS; malvern PA 19355
• MDR Report Key: 4792810
• MDR Text Key: 5852737
• Report Number: MW5042794
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening