MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. GE COROMETRIC MINI TELEMETRY; SYSTEM, MONITORING, PERINATAL

Device Problems Disconnection (1171); Energy Output Problem (1431)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

Ge corometric mini telemetry system was plugged into wall electrical outlet and connected to the pt during the night.The charger became disconnected for the telemetry box and remained plugged into the electricity.The pt sustained small burn on her skin.The pt and her fetus had no long term consequence of the event.Diagnosis for use: fetal monitoring.

• Brand Name: GE COROMETRIC MINI TELEMETRY
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD.
• MDR Report Key: 16086066
• MDR Text Key: 306623308
• Report Number: MW5114111
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White