MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. 259CX CTG MONITOR; SYSTEM, MONITORING, PERINATAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death, Intrauterine Fetal (1855)

Event Type  Death  

Manufacturer Narrative

Ge healthcare¿¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

The hospital reported an alleged failure of the fetal monitor to re-alarm for a low fetal heart rate.The fetus was stillborn.

Manufacturer Narrative

Ge healthcare was made aware of an event involving a still-birth that occurred sometime in 2018.No allegation was made against ge healthcare equipment.Ge healthcare has not been provided any information regarding the clinical scenario that led to the event or regarding the patient history.As part of the hospital's internal investigation, ge healthcare was asked about the normal operation of the alarms of the corometrics monitors and additional information regarding the implementation of alarm.Ge healthcare was able to respond to the hospital's request by providing information available from the manual.Ge healthcare product engineering performed an investigation of this event.From the event information provided by the hospital , there is no evidence that the device caused or contributed to the adverse event that occurred and the unit is working as intended.The customer has confirmed that there is no issue with the equipment.The root cause has been identified as a user error쳌.

• Brand Name: 259CX CTG MONITOR
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD.; 4, kadugodi industrial area,; bangalore 56006 7; IN 560067
• MDR Report Key: 8537514
• MDR Text Key: 142687716
• Report Number: 9617277-2019-00001
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K072976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death