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

Model Number M2705A

Device Problem Unable to Obtain Readings (1516)

Patient Problem Abnormal Blood Gases (1034)

Event Date 01/29/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported several instances where the fetal heart rate is not able to be picked up, but the ultrasound transducer picks up the maternal heart rate.A patient was harmed.The infant required resuscitation at birth and therapeutic hypothermia due to bad cord gas results.The device was used for monitoring at the time of the alleged malfunction.There was no further information about the patient's condition provided beside the fact that infant was delivered to other facility for therapeutic hypothermia.

Manufacturer Narrative

The customer reported, that the physician and nursing staff were verifying the mother¿s heart rate via a radial check and spo2 saturation probe.They repositioned the us transducer multiple times without success.The field service engineer (fse) checked the monitor during an on site visit.The fse confirmed that the device is fully functional without any technical problem.The clinical specialist (cs) evaluated the problem with the customer via phone and during onsite visit.The cs has reviewed the monitoring methods and collected traces to discuss them with the customer.During a second visit the cs supervised the monitoring during a deliver.The device was working without any issues.The provided traces and logs were reviewed by the product support engineer.This trace shows coincidence alarms between the fetal heart rate and the maternal pulse and a loss of signal from time to time likely due to a bad position of the transducer.The trace shows that the device is working as specified.No trouble could be identified.According to the cs, the customer has an application issue with the new fetal monitor system to pick up the fetal heart rate versus maternal heart rate.The us transducer was latching onto the mhr rather than the fhr during the pushing stage.The toco transducer involved in this incident was taken out of service and shipped to philips for evaluation.The transducer did not arrive in the factory and could not been evaluated any further.The customer was instructed about correct usage of gel, repositioning by taking the us off the skin and replacing the transducer.The cs re-emphasized that other measures are available for verifying any vital sign coming from the monitor, including sp02, ecg and fetal scalp electrode.To reduce the possibility of mistaking maternal heart rate for fetal heart rate (fhr) philips recommend that the customer should monitor both maternal and fetal heart rates, especially during the later stages of labor.The cross-channel verification functionality (ccv) of the fetal monitors compares all monitored heart rates (maternal and fetal), and indicates automatically whether any two channels are picking up the same signal, or monitoring similar values.If the fetal monitor detects that any channels have the same or similar values, the coincidence inop is issued with an inop tone that can have a configurable delay.In addition, yellow question marks appear next to the numeric on the touch screen that have the same or similar values.On the recording trace there is also a question mark from the point where recorded traces continuously overlap.Fhr detection by the monitor may not always indicate that the fetus is alive.Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded fetal heart rate.Philips recommends in the instruction for use (ifu) the following when a coincidence of heart rates is detected: "1.Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or pinard stethoscope.2.Manually determine the maternal pulse and compare with the fetal heart rate sound signals from the loudspeaker.3.Reposition the transducer, or ensure that the fetal scalp electrode is placed correctly, until you receive a clear signal and the monitor is no longer issuing the ¿coincidence inop¿.4.In case of difficulties deriving a stable maternal pulse reading using the toco mp or cl toco+ mp transducer, use spo2 or the cl spo2 pod instead.In case of similar problems with the pulse measurement from spo2, use mecg instead.Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via toco mp).5.If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography." the problem was solved by instructing the customer about correct usage of fetal monitor system.The product remains at the customer site.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.

Manufacturer Narrative

Udi number added.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6394510
• MDR Text Key: 69563230
• Report Number: 9610816-2017-00076
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 1 DA