MAUDE Adverse Event Report: GE HEALTHCARE GE COROMETRICS NAUTILUS 2264HAX TOCO TRANSDUCER WITH KNOB; TOCOTRANSDUCER

Model Number 2264LAX

Device Problems Crack (1135); Material Perforation (2205); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete; however, initial visual inspection identified that the membrane was torn and the case was cracked.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

The device was returned for evaluation as the device serial number was listed on the recall advisory.There was no device malfunction nor adverse event reported; however, initial visual inspection identified that the membrane was torn and the case was cracked.

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found that the case was cracked and the membrane was torn.Technical visual inspection found that the cable was in good condition and was working properly.The device had a broken diaphragm/membrane on the bottom case.The bottom case cover was replaced.Gain measurement was performed.Parameter, cable, membrane, shake/rattle, and voltage/gain tests were performed and passed.It was determined that this was related to the previous repair and the root cause was determined to be a defective case with a peeled membrane/diaphragm.This type of event will continue to be monitored.Brand name - correction.

• Brand Name: GE COROMETRICS NAUTILUS 2264HAX TOCO TRANSDUCER WITH KNOB
• Type of Device: TOCOTRANSDUCER
• Manufacturer (Section D): GE HEALTHCARE; 8880 gorman rd; laurel MD 20723
• MDR Report Key: 9154179
• MDR Text Key: 165041270
• Report Number: 3007409280-2019-00031
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K072976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2264LAX
• Device Catalogue Number: FFCM3205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1