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

Model Number FM50

Device Problem Communication or Transmission Problem (2896)

Patient Problems Low Apgar Score (1718); Bradycardia (1751); Death (1802); Encephalopathy (1833); Hypoxia (1918); Ischemia (1942); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 10/14/2014

Event Type  Death  

Event Description

Female who has had one pregnancy and no live births (g1p0) presented in active labor (40 to 42 weeks) to labor and delivery with contractions.During the second stage of labor, an emergent c-section required due to fetal bradycardia that was not apparent on the electronic fetal monitor until an internal fetal scalp electrode was placed.At the time, the bradycardia was discovered, the c-section was performed.Baby had triple nuchal cord, born with no detectible heart rate and neonatal resuscitation program was initiated.Patient transported to nicu from or suite in critical condition.Ultimately infant was resuscitated post partum, transferred to denver where they determined the infant had no brain activity thus transferred back.Post-term infant with 41 completed weeks of gestation.In brief, the baby was delivered asystolic, required full resuscitation including intubation, positive pressure ventilation (ppv), chest compressions, multiple epinephrine doses and central line placement.Her apgars were 0, 0, and 0 at 1, 5 and 10 minutes.Heart rate was obtained approximately 13 minutes into resuscitation.Severe hypoxic ischemic encephalopathy; family withdrew life support and infant expired two days later.

• Brand Name: AVALON FM50
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 4219211
• MDR Text Key: 5002081
• Report Number: 4219211
• Device Sequence Number: 1
• Product Code: HGM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FM50
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2014
• Patient Sequence Number: 1
• Treatment: PULSE OXIMETER CORD; EXTERNAL ULTRASOUND AND TOCO DEVICES AS WELL AS
• Patient Outcome(s): Death
• Patient Age: 29 YR
• Patient Weight: 83