MAUDE Adverse Event Report: GE HEALTHCARE GE COROMETRICS NAUTILUS 2264LAX TOCO TRANSDUCER WITH WING; TOCOTRANSDUCER

Model Number 2264LAX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned to avante health solutions (ahs) for evaluation.Visual inspection identified that the bottom case had not been changed during previous repair; however, there is no known possibility of this causing overheating of the device nor patient harm.The correct ahs cable was connected to the fetal transducer at the time of the previous repair.Testing was performed by keeping the device plugged in for 48 hours straight which determined that there was no heat generating from the device.The cable worked as expected; however, there was a torn membrane.A definitive root cause for the reported patient burn cannot be determined; however, it is possible that the patient had a negative reaction to type of gel being used during the use of the device.No further action is required.Avante health solutions will continue to monitor this type of event.

Event Description

Reportedly, the patient was burned during use of the fetal transducer.There was no report of intervention.No additional event or patient information is available.

• Brand Name: GE COROMETRICS NAUTILUS 2264LAX TOCO TRANSDUCER WITH WING
• Type of Device: TOCOTRANSDUCER
• Manufacturer (Section D): GE HEALTHCARE; 8880 gorman rd; laurel MD 20723
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672
• MDR Report Key: 8773666
• MDR Text Key: 150526134
• Report Number: 3007409280-2019-00001
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2264LAX
• Device Catalogue Number: FFCM3260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other