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

Model Number M2703A

Device Problem Insufficient Information (3190)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 09/30/2014

Event Type  Death  

Event Description

The customer stated that the "fetus was born death/stillbirth." additional information has been requested.

Manufacturer Narrative

(b)(4).A follow up report will be submitted after philips obtains more information concerning this event.

• Brand Name: AVALON FM30 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str. 2; boeblingen 7103 4; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786597844
• MDR Report Key: 4195596
• MDR Text Key: 4960333
• Report Number: 9610816-2014-00261
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K052795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M2703A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2010
• 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