MAUDE Adverse Event Report: GE 250CX - SERIES (COROMETRICS); PERINATAL MONITORING SYSTEM

Model Number 250CX-SERIES

Device Problems Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

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

Event Date 04/19/2017

Event Type  malfunction  

Event Description

Nurse reported she was unable to pick up fetal heart tones clearly and heard a lot of static and feedback.Changed out the equipment with success.Original ultrasound tagged and sent to biomed.For inspection.Manufacturer response for fetal monitor, 250cx - series (per site reporter): returned for repair.

• Brand Name: 250CX - SERIES (COROMETRICS)
• Type of Device: PERINATAL MONITORING SYSTEM
• Manufacturer (Section D): GE; 540 w northwest hwy.; barrington IL 60010
• MDR Report Key: 6593588
• MDR Text Key: 76034569
• Report Number: 6593588
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 250CX-SERIES
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 20 YR
• Patient Weight: 122