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

Model Number M2705A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 11/20/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer called for application support to pull data from a monitor to see if alarms were visible and acknowledged.The customer reported that they had an adverse outcome where there was a concern with regard to heart rate coincidence between the fetal and the maternal heart rate.The device was used for monitoring at the time of the alleged malfunction.The customer stated that there was a delivery with an adverse outcome.No further details about the adverse event were made available by the customer.

Manufacturer Narrative

The issue was evaluated by the clinical specialist (cs) who checked whether the monitor's alarm configuration was set up as discussed with the customer during installation.The cs confirmed that all alarms were enabled correctly and the alarm pause mode was disabled.The cs stated that the trace of the particular adverse event showed question marks indicating the coincidence alarms (as intended when there is a coincidence between the measurements of fetal and maternal heart rate).Despite requested by the cs, the customer did not want to provide the trace for further evaluation by philips.Hence, no further investigation was possible.The cs confirmed that the alarm configuration was set correctly and that the trace of the particular adverse event showed question marks indicating the coincidence alarms.The fse performed a functional check of the monitor at the customer site and confirmed that the monitor worked as specified during testing.The product remains at the customer site.The device worked as intended and no malfunction of the device occurred.The alarm configuration was set correctly and the trace of the particular adverse event showed question marks indicating the coincidence alarms.No further investigation or action is warranted.

Event Description

The customer called for application support to pull data from a monitor to see if alarms were visible and acknowledged.The customer reported that they had an adverse outcome where there was a concern with regard to heart rate coincidence between the fetal and the maternal heart rate.The customer reported that the newborn required extensive resuscitation and later died.No further details about the adverse event (e.G.Patient data) were made available by the customer.

• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7063811
• MDR Text Key: 93140581
• Report Number: 9610816-2017-00373
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071800
• 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
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2705A
• Device Lot Number: TBD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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): Death; Other
• Patient Age: 1 DA