MAUDE Adverse Event Report: GE HEALTHCARE GE HEALTHCARE ULTRASONIC PULSED DOPPLER IMAGING SYSTEM; ELECTRONIC FETAL MONITOR

Model Number 259CX-D COROMETRICS

Device Problems Image Display Error/Artifact (1304); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Advance (2524); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 03/11/2018

Event Type  malfunction  

Event Description

When using the ge efm 259cx-d multiple safety issues were identified.Ge representatives were contacted and came on site to assist; however, the issues persisted.The monitor was removed from service and replaced with another manufacturer's product.Maternal hr does not automatically trace on paper: requires repeated manual adjustments, delay in establishing fhr initially and when patient is pushing, difficulty monitoring uterine contractions, bp not working, fse: fhr suddenly stopped working, took 15 minutes to reestablish, nurses having to use "tricks" to get accurate fhr tracings, background noise on the us is too loud, fhr too soft and difficult to hear, printer paper won't advance, if paper runs out, unable to reprint tracing on new paper, (b)(4) does not return to baseline when patient returns and replugs after going to the restroom and us monitor was being held in the air and not on patient and was reading fht's of 140's.

• Brand Name: GE HEALTHCARE ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• Type of Device: ELECTRONIC FETAL MONITOR
• Manufacturer (Section D): GE HEALTHCARE; waukesha CA 51388
• MDR Report Key: 7373088
• MDR Text Key: 103785928
• Report Number: MW5076133
• Device Sequence Number: 0
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 259CX-D COROMETRICS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1