MAUDE Adverse Event Report: GE HEALTHCARE ELECTRONIC FETAL MONITOR COROMETRICS ELECTRONIC FETAL MONITOR; SYSTEM, MONITORING, PERINATAL

Model Number 259CX-D COROMETRICS

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2018

Event Type  malfunction  

Event Description

When using the ge efm 259cx-d multiple safety issues were identified.Ge reps were contacted and came on site to assist, however, the issues persisted.The monitor was removed from service and replaced with another mfr's product.Maternal hr does not automatically trace on paper.Requires repeated manual adjustments.Delay in establishing fhr initially and when pt is pushing.Difficulty monitoring uterine contractions.Bp not working.Fse: fhr suddenly stopped working, took 15 mins 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.Toco does not return to baseline when pt returns and replugs after going to the restroom.Us monitor was being held in the air and not on pt and was reading fhts of 140's.

• Brand Name: ELECTRONIC FETAL MONITOR COROMETRICS ELECTRONIC FETAL MONITOR
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): GE HEALTHCARE; waukesha WI 53188
• MDR Report Key: 7373008
• MDR Text Key: 103667542
• Report Number: MW5076124
• Device Sequence Number: 1
• 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

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2018
• 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