MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM20 FETAL MONITOR

Model Number M2702A

Device Problem Defective Device (2588)

Patient Problem Death (1802)

Event Date 07/23/2017

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested.Date of event has been requested.Serial number unavailable at time of report.

Event Description

The customer contacted philips with questions regarding an error with the avalon fetal monitor and a death of a newborn was reported.The newborn died.

Manufacturer Narrative

The reported issue was investigated via remote support.The customer's physician reported that a female fetus was stillborn and could not be resuscitated on (b)(6) 2017.According to the physician, a coincidence alarm was announced, alerting the clinical staff to the fact that the fetal heart rate (fhr) might no longer be recorded, but rather the maternal heart rate (mhr).The mhr was displayed with a thick line on the traces after the loss of the fhr, instead of with a thin line as expected by the clinical staff, which led them to believe that the fhr was still recorded.The trace was submitted and forwarded to the philips research & development department (r&d) for evaluation.According to r&d, the mhr is not printed differently when the fhr is lost, however, the line width for the respective trace is adjustable.Depending on the settings, the thickness of the mhr can vary, however, the thickness of the trace does not change with the loss of the fhr.The customer was instructed accordingly.The customer was provided with the excerpts from the instructions for use regarding the coincidence alarm and information regarding the line thickness for the mhr and fhr.The device remains at the customer site.Based on the information provided, no malfunction of the fetal monitor was identified and the device worked as intended.This issue was caused by user misunderstanding.No further investigation or action is warranted.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 FM20 FETAL MONITOR
• Type of Device: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7752006
• MDR Text Key: 116076059
• Report Number: 9610816-2018-00192
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K052795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2702A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29 YR
• Patient Weight: 84