MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. 250CX SERIES; SYSTEM, MONITORING, PERINATAL

Model Number 2036400-005

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The hospital reported the device is currently in quarantine.Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information available at time of mdr filing.Incident date not provided to date.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported fetal demise related to the misinterpretation of noise occurring during use of the coro 250 monitor.The nurse reportedly interpreted the lack of fetal heart rate as typical noise they experience when using the monitor.

Manufacturer Narrative

The unit was tested and found to be functioning as intended.Biomed confirmed the use of third party repaired transducers being used at the customer site.The actual transducers used during the reported event was not available for valuation as the customer was unsure about the actual transducers in use during the reported event.The investigation test results with our approved, functioning ge ultrasound probes when used alongside the masimo spo2 sensors do not support the claim of humming noise and flat tracing resulting from this humming noise.The observed humming sound may be due to the use of third party repaired transducers which would compromise the grounding shield of the cable which would in turn result in the transducers picking up external noise from a nearby masimo spo2 transducer.A damaged grounding shield will not result in complete loss of fhr values but will reflect random values on the display due to the external noise.Ge clearly states in product labelling to only use ge approved parts.The root cause of customer allegation could not be determined nor duplicated as the customer was unsure about the actual transducers in use during the reported event.The user was advised to use only ge approved parts in the service manual.

• Brand Name: 250CX SERIES
• 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: 9950216
• MDR Text Key: 187373496
• Report Number: 9617277-2020-00001
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2036400-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death