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

Model Number M2705A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 12/24/2019

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that on the (b)(6) 2019, the fetal monitor did not alarm for the loss of the fetal heart rate.The baby expired.

Manufacturer Narrative

Philips field service engineer (fse) went on-site to evaluate the device.Philips fse stated that there was a c-section performed and that type of birth was stillbirth.Philips fse confirmed that the fetal monitor was tested together with the ultrasound transducer and the patient module.Each device passed when connected to sockets 3 and 4 on the monitor.Devices did not work on socket 1 and there was an intermittent failure while on socket 2.Philips fse tested each on all the sockets and these results were consistent.The customer was not able to answer which sockets were being used during the event.Customer removed the fetal monitor from use.Philips product support engineer (pse) reviewed the reported issue.Pse evaluated the patient monitor configuration provided at the time of the reported event.Pse observed that the alarm configuration of the fetal monitor was changed by the user (the configuration was not setup the same compared to when the device was shipped initially).At the time of the reported event , patient monitor configuration showed that the limits for fetal heart rate (fhr) were set between 100 (low) and 160 (high) bpm and alarms were on.Alarm volume was set to level ¿1¿, which is considered very quiet.Based on the limits and delays, the alarm did not alarm immediately.There was no signal from the baby coming for continuous 90 seconds, which is considered a long time.Philips pse could not confirm that the monitor contributed to the reported event outcome.Customer decommissioned the fetal monitor.No further contact was established by the customer regarding the reported device and issue and no additional information was provided.Based on the available information, the exact cause and its resolution could not be established.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: PERINATAL MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9646410
• MDR Text Key: 176952769
• Report Number: 9610816-2020-00037
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K071800
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 3