MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM30 FETAL MONITOR

Model Number M2703A

Device Problems Imprecision (1307); Incorrect Measurement (1383)

Patient Problem Hypoxia in Utero (2210)

Event Date 02/09/2022

Event Type  Injury  

Event Description

The customer reported that on the avalon fm30 fetal monitor the tracing had a restricted aspect that could indicate a possible fetal hypoxia and an episiotomy was performed.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Reported issue was reviewed by philips research and development engineering, product support engineering and clinical specialist: the avalon fm30 fetal monitor prints the time, date, recorder speed, and current parameter setup information in the trace header when first switched on, in a periodic time stamp every ten minutes after, and if the monitoring modes change.The paper speed is printed on the trace and the hcp should notice and be aware.In this case it seems like different departments and/or teams missed out on the fact that the wrong paper speed was configured.Users must familiarize themselves with all the instructions included in the instructions for use (ifu) before starting to monitor patients.The responsible personnel who is responsible at the hospital for the setup at the l&d ward should be aware of the customization/ configuration and configure the devices for the hcp.In addition, philips key market forwarded an email on 11-mar-2022 stating that the philips distributor provided information to swissmedic confirming that there was no problem with the avalon fm30 fetal monitor.Issue was related to the wrong configuration setting of the avalon fm30 fetal monitor.The device worked as intended and there was no malfunction of the avalon fm30 fetal monitor.

Event Description

The customer reported that on the avalon fm30 fetal monitor the tracing had a restricted aspect that could indicate a possible fetal hypoxia.There was alleged emotional impact for the patient who underwent a birth experience described as "stressful and panicky".

• Brand Name: AVALON FM30 FETAL MONITOR
• Type of Device: AVALON FM30 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13723899
• MDR Text Key: 286955960
• Report Number: 9610816-2022-00120
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: 00884838000414
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2703A
• Device Catalogue Number: M2703A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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): Required Intervention