MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM50 FETAL MONITOR; PERINATAL MONITORING SYSTEM

Model Number	M2705A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/26/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient information was requested, unavailable at the time of this report.A follow up report will be submitted after philips obtains more information concerning this event.
Event or Problem Description
The customer reported that a philips fm50 fetal monitor was in use during a critical incident that resulted in an fetal death.The device was used for monitoring at the time of the alleged malfunction.
Additional Manufacturer Narrative
The customer stated there was an unexpected c-section due to the baby's failure to descend on (b)(6) 2017.The approximate duration of the birth was from 13:50 to 17:30.The customer did a c-section and thought everything was well, however, upon delivery the baby was deceased.The fm50 was removed from service by the hospital's clinical engineering department, and was returned to the factory together with the following devices: - device type : m2705a avalon fetal monitor fm50, serial number (sn): (b)(4) with fw revision: a.06.31.- device type: m2736a avalon us transducer, serial number: (b)(4), manufactured may 2016.- device type: m2734b avalon toco mp transducer, serial number: (b)(4), manufactured march 2017.The product support engineer (pse) conducted a performance test on the returned equipment.No trouble was found, the devices were fully operational and working as specified.The alarm review (in service mode) was checked on the monitor.A general test on the alarm functionality was performed, the alarming worked as specified.As the monitor was used after the incident, the alarms and stored data for the incident dated (b)(6) 2017, were not available anymore due to limited storage of traces and alarm history.The customer also provided the traces of the reported incident.The traces were reviewed by the product support engineer (pse) and an external senior midwife working closely with philips.During the evaluation of the traces, it was noted that the avalon toco mp transducer listed on the traces was not the same transducer that had been returned to the factory for evaluation (sn: (b)(4) on trace but sn: (b)(4) returned).Both pse and midwife observed that the cardiotocography is clinically conspicuous from the beginning.Restricted oscillation could be observed.The heart rate curve of the fetus is not fluctuating around the baseline when labor pain occurs.From 16:04 onwards, there is no safe recording of the child anymore.The mother was measured with the ultrasound transducer by mistake although the transducer actually should pick up the fetal heart rate.Coincidence alarms were reported correctly and appear on the traces regularly and repetitively.There are no indications for a malfunction of the device in the recording.The customer additionally sent a second trace of another examination from the monitor.This trace also shows multiple coincidence alarms between the fetal heart rate and the maternal pulse.The trace shows that the device was working as specified during this examination as well.The avalon series fetal monitors utilize ultrasound technology to measure the fetal heart rate non-invasively.It is well documented in the avalon instructions for use (ifu), that phenomena/artifacts such as halving or doubling of the fetal heart rate, or switching between maternal and fetal heart rate can occur when using this method.The equipment was sent back to the customer, 2 of 3 involved devices have been evaluated.No trouble could be found with the evaluated devices and traces.The problem was likely caused by insufficient knowledge of the functionality, and the customer was instructed accordingly.The products remain at the customer site.

• Brand Name: AVALON FM50 FETAL MONITOR
• Common Device Name: PERINATAL MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6633726
• Report Number: 9610816-2017-00181
• Device Sequence Number: 803797
• Product Code: HGM
• Combination Product (Y/N): N
• PMA/510(K) Number: K071800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 1 DA