MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM30 FETAL MONITOR

Model Number M2703A

Device Problems Display or Visual Feedback Problem (1184); Invalid Sensing (2293)

Patient Problem Cardiopulmonary Arrest (1765)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer reported that the sensors probably provide faulty images.Customer reported that the fetal monitor value did not indicate a problem with the newborn.After delivery, it become obvious that baby needed to be reanimated and was sent to a different hospital for intensive care.The technician of the distributor informed philips that the involved device was removed from service.The distributor has no information about the patient status after the incident.

Manufacturer Narrative

The distributor investigated the problem at the customer side.The device including two transducers which were removed from service and send to the philips factory for further evaluation.Customer received a loaner device for the time when the devices were not available.The philips factory tested the device and confirmed that the fetal monitor is fully functional without any problem.No malfunction could be identified.As the software (sw) version was quite old, the sw was updated to g.02.2.The previous sw reversion was outdated but had no negative effect to the monitoring functionality.No repair action was performed.The device was send back to the customer.The customer provide the trace of the patient incident.The trace were reviewed by a product support engineer.The trace shows many drop out for cardiac output of the mother (pulse) and the fetus (fhr).Additionally, the trace shows printed coincidence question marks for coincidence of maternal pulse and fhr.When the maternal pulse and fhr are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor¿s screen above both of the corresponding numeric (in this case maternal pulse and fhr).Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary.The philips bench confirmed that the device is fully functional which is considered as all that is warranted for this issue.The product returned to the customer site.The philips bench confirmed that the fetal monitor is fully functional without any problem.A review of provided traces found evidence of coincidence detection between maternal and fhr with markers to indicate this.A careful trace analysis performed by a health professional during monitoring of delivery would have indicated an issue that heart rate are not captured correctly.Product labeling adequately describes coincidence detection functionality.The monitor provided warnings as designed.Hence, this complaint does not represent a product/part failure.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

The distributor investigated the problem at the customer side.The device including two transducers which were removed from service and send to the philips factory for further evaluation.Customer received a loaner device for the time when the devices were not available.The philips factory tested the device and confirmed that the fetal monitor is fully functional without any problem.No malfunction could be identified.As the software (sw) version was quite old, the sw was updated to g.02.2.The previous sw reversion was outdated but had no negative effect to the monitoring functionality.No repair action was performed.The device was send back to the customer.The customer provide the trace of the patient incident.The trace were reviewed by a product support engineer.The trace shows many drop out for cardiac output of the mother (pulse) and the fetus (fhr).Additionally, the trace shows printed coincidence question marks for coincidence of maternal pulse and fhr.When the maternal pulse and fhr are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor¿s screen above both of the corresponding numeric (in this case maternal pulse and fhr).Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary.The philips bench confirmed that the device is fully functional which is considered as all that is warranted for this issue.The product returned to the customer site.The philips bench confirmed that the fetal monitor is fully functional without any problem.A review of provided traces found evidence of coincidence detection between maternal and fhr with markers to indicate this.A careful trace analysis performed by a health professional during monitoring of delivery would have indicated an issue that heart rate are not captured correctly.Product labeling adequately describes coincidence detection functionality.The monitor provided warnings as designed.Hence, this complaint does not represent a product/part failure.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.

• Brand Name: AVALON FM30 FETAL MONITOR
• Type of Device: FETAL MONITOR
• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6269763
• MDR Text Key: 65502345
• Report Number: 9610816-2017-00015
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2703A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening