MAUDE Adverse Event Report: GE HEALTHCARE VOLUSON E8; ULTRASONIC PULSED ECHO IMAGING SYS, ITX, IYN

Model Number BT09

Device Problem Incorrect Measurement (1383)

Patient Problem Pregnancy (3193)

Event Date 10/30/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 ge healthcare received a report from a high-risk pregnancy center lead clinical sonographer that a voluson e8 ultrasound system, k8e10807, had varying doppler velocity measurements when using both the 4c-5 and rm6c probes during the mca portion of an (b)(6) study.The hospital reported that a c-section was performed on (b)(6) 2014 to deliver a 35-week-old fetus suspected of having fetal anemia due to a mca velocity measurement provided by the voluson e8 when using the rm6c probe.However, when the baby was born the hematocrit was normal (i.E.No anemia).Neither the mother nor the baby suffered any negative consequences as a result of the unnecessary c-section.Beginning on (b)(6)2014 and through (b)(6)2014 a ge field engineer troubleshot the issue and finally replaced the computer and the hard disk on voluson e8 k8e10807, and it's associated software, with like parts.After that the hospital stated that the issue is solved by performing doppler velocity comparison measurements on a patient.The computer, hard disk drive and log files were provided to the manufacturer's engineering team to further investigate the issue.Ge healthcare's investigation is ongoing.A follow up report will be provided after the investigation has been completed.

Manufacturer Narrative

The hospital reported that they internally confirmed on (b)(6) 2014 that the velocities are different between the 4c-d and rm6c probes when used on voluson e8 k8e10807 with another patient, and they confirmed that performing the same measurements using the same probes on another voluson e8 ultrasound system did not have the same quantity of difference.In other words ,the same measurement using the two different probes on another ultrasound system produced comparable results, while on system k8e10807 the measurement difference was beyond what was typically expected.Therefore, they suspected the voluson e8 k8e10807 of producing incorrect mca doppler velocity measurements when using the rm6c probe.Retrospectively, the mca velocity measurement (performed on (b)(6)2014) was suspected to be false, in which case the c-section may have been unnecessary.

• Brand Name: VOLUSON E8
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYS, ITX, IYN
• Manufacturer (Section D): GE HEALTHCARE; zipf ; AU
• Manufacturer (Section G): GE HEALTHCARE; zipf ; AU
• Manufacturer Contact: james giles ; 3000 n. grandview blvd.; w450; waukesha, WI 53188 ; 2625482089
• MDR Report Key: 4359782
• MDR Text Key: 5236644
• Report Number: 8020021-2014-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BT09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization