MAUDE Adverse Event Report: MONICA HEALTHCARE LTD. MONICA FETAL MONITORING SYSTEM; SYSTEM, MONITORING, PERINATAL

Model Number GTIN(01): 05060433670053

Device Problems Device Contamination with Body Fluid (2317); Scratched Material (3020)

Patient Problems Erythema (1840); Inflammation (1932)

Event Date 11/21/2018

Event Type  malfunction  

Event Description

The nurse removed the wireless monica monitoring system from the patient's abdomen as it kept alarming -stating to adjust electrode.Upon removal of the electrodes, the nurse found the skin was reddened and inflamed.There was one electrode on the patient's left side that was an abrasion and was blood tinged.

• Brand Name: MONICA FETAL MONITORING SYSTEM
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): MONICA HEALTHCARE LTD. ; nottingham NG 10 5QG; UK NG 10 5QG
• MDR Report Key: 8138920
• MDR Text Key: 129775682
• Report Number: MW5081895
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GTIN(01): 05060433670053
• Device Lot Number: (10):500904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR