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 11/16/2014

Event Type  Death  

Event Description

The customer reported that following an active discussion file review of morbidity and mortality in maternity (rmm), the medical staff had two technical issues that philips may be able to answer.

Manufacturer Narrative

(b)(4).A f/u report will be submitted after philips obtains more info concerning this event.

• Brand Name: AVALON FM30 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packwrd str. 2; boeblingen 7103 4; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minutemann road; andover, MA 01810 ; 9786597844
• MDR Report Key: 4340025
• MDR Text Key: 5180071
• Report Number: 9610816-2014-00315
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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: 11/14/2014
• Was Device Evaluated by Manufacturer?: No
• 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