MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. COROMETRICS MONITOR; SYSTEM, MONITORING, PERINATAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Brain Injury (2219)

Event Date 01/25/2014

Event Type  Injury  

Manufacturer Narrative

No information is available at this time regarding patient information.No information is available at this time regarding model and/or serial number.Report source is a lawsuit.No information is available concerning the serial #, thus date of manufacture is not known.

Event Description

Ge healthcare has received notice of a lawsuit, alleging that "the corometrics monitor mistakenly monitored and recorded the maternal heart rate at times during the labor, including the second stage.As a result, the doctors and nurses were misled into thinking the fetus was fine when it was not, and needed to be delivered by c-section." the baby reportedly "suffered brain cell death and brain damage due to hypoxic ischemic encephalopathy".

Manufacturer Narrative

No unit serial number, complaint details, heart rate strip charts, and clinical assessments are available.In addition, there were no previous complaints from the customer describing this type of event.Therefore, no root cause could be determined due to the limited information available.Should further event information be received to enable ge healthcare to conduct an investigation, a second supplemental mdr will be provided.

• Brand Name: COROMETRICS MONITOR
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD.; 4, kadugodi industrial area; bangalore 56006 7; IN 560067
• Manufacturer (Section G): WIPRO GE HEALTHCARE PRIVATE LTD.; 4, kadugodi industrial area; bangalore 56006 7; IN 560067
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 6063550
• MDR Text Key: 58654093
• Report Number: 9617277-2016-00001
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other