MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM20 FETAL MONITOR

Model Number	M2702A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/13/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer is questioning if the maternal heart rate (mhr) can be recorded as the fetal heart rate (fhr).There was a neonatal patient death reported 3 days after the delivery.The device was used for monitoring at the time of the alleged malfunction.
Additional Manufacturer Narrative
During the birth on (b)(6), a drop of the fhr was seen at 14:40.The baby was born at 14:59 with an apgar score of 2, measured at 1 minute and 5 minutes after birth.The apgar score is a method to quickly summarize the health of newborn children.The baby passed away 3 days after birth due to hypoxic ischemic encephalopathy (hie).The customer provided the trace for the adverse event.The software version of the device is f.01.55.The trace it self was printed from a surveillance system, thus no information about the transducer and used monitor was available on the trace.The patient was monitored with a toco transducer and an ultrasound transducer.The maternal heart rate was not monitored, thus no coincidence notation between a maternal heart rate and a fetal heart rate was possible for instances when the ultrasound transducer detected the maternal pulse (e.G.From the aorta abdominalis) instead the fetal heart rate.The trace has been evaluated by a philips physician and an external midwife.They stated that the trace starts with showing signs of compromised fetal well-being through low variability.At 13:36 the fetal trace shows additional decelerations as another sign for clinical deterioration.At 14:06 the fetal trace changes again.The trace shows less decelerations and normal variability.The fhr did not react to contractions any more.This would be an unlikely, sudden clinical improvement of the fetus and is probably caused by the ultrasound switching to the prominent pulse source of the mother.The fetal heart movements are probably too weak or gone from that moment onwards.The device was tested by an engineer, no malfunction could be identified.The problem was solved by instructing the customer which is considered as all that is warranted for this issue.The product remains at the customer site and is used in the labor and delivery ward.Additionally, the available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.
Additional Manufacturer Narrative

• Brand Name: AVALON FM20 FETAL MONITOR
• Common Device Name: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6951421
• Report Number: 9610816-2017-00333
• Device Sequence Number: 12138158
• Product Code: HGM
• Combination Product (Y/N): N
• PMA/510(K) Number: K052795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M2702A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017; 10/11/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/07/2017; 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 DA