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

Model Number M2703A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problems Non specific EKG/ECG Changes (1817); Encephalopathy (1833); Hypoxia in Utero (2210)

Event Date 06/05/2014

Event Type  Injury  

Event Description

The customer reported per that, they started monitoring the fetal heart rate (fhr) of a single fetus externally, using an ultrasound transducer.The staff observed some deceleration and changed to monitoring a single fetal heart rate via direct ecg (decg), using a spiral fetal electrode without disconnecting the ultrasound transducer.The staff continued monitoring with both options connected.The decg fhr appeared to increase but this was due to the tace separating fhr by an offset of +20 bpm.The staff thought the deceleration had reverted, when in fact it was still a problem - the +20bpm scale was noted by practitioners approximately 25 minutes following the commencement of decg monitoring.The fhr was thought to be in the range of 110bpm, when it was actually around 90bpm.The baby has hypoxic ischemic encephalopathy - customer believes to be at grade 3 - 4.The customer states that the practitioners did not notice that the increase in fhr was related to the #20 bpm scale, they did not realize the +20 bpm scale was the reason for the apparent increase in fhr.It is believed that trace separation was on but this has not been confirmed.

Manufacturer Narrative

(b)(4).A follow up report will be submitted upon completion of the investigation.

• 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 rd.; andover, MA 01810 ; 9786597844
• MDR Report Key: 3940905
• MDR Text Key: 18024620
• Report Number: 9610816-2014-00185
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M2703A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2014
• 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