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

Model Number M2705A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Death (1802); Death, Intrauterine Fetal (1855)

Event Date 09/16/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow up report will be submitted once the investigation is complete.

Event Description

The customer submitted a pimr and stated there was a misidentification of maternal heart rate as fetal, and the fetus died.

Manufacturer Narrative

The philips clinical consultant and philips ob monitoring solution specialist had an onsite visit on (b)(4) 2015.Addressing the issues of reading mom vs baby on the strips and addressing protocol on monitoring both patients and distinguishing mom¿s hr by checking the radial pulse to confirm and compare to the hr on the strip.The philips clinical consultant and philips ob monitoring solution specialist onsite reviewed the monitors with the staff.No trouble was found.The philips clinical consultant also reinforced training with the avalon fm50 and transducer station.The philips clinical consultant also discussed using the spo2 to get a pulse if the maternal pulse is lost during a contraction or end stage labor.Over all there was no problem with the philips monitoring system identified.The customer was receptive, open with their discussion and feedback.The m2705a avalon fm50 fetal monitor s/n: (b)(4) was tested onsite by the philips clinical consultant and the customer.This evaluation has revealed no abnormalities and the device passed.Additional training about the ifu content was provided to resolve the use issues.The device remains at the customer site for use.No further investigation or action is warranted.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: PERINATAL MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5155541
• MDR Text Key: 28458782
• Report Number: 9610816-2015-00246
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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