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

Model Number M2703A

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that they did not receive an alarm when the device had no fetal heart rate tracing for 40 minutes.The device was in use on patient at time of event, there was no adverse event reported.

Manufacturer Narrative

Philips received a complaint on the avalon fm30 fetal monitor indicating that there were no traces nor alarm for 40 minutes.The complaint was escalated for technical investigation, and the provided information was reviewed by a product support engineer (pse).The pse advised that the last time the us transducer reported a valid fetal heart rate (fhr) was at approximately 12:54:30.One minute later, a ¿signal loss¿ for fhr1 (rcf1) was issued from the fetal monitor (12:55:32), which is a visual and audible alarm.This alarm was acknowledged by pressing ¿silence¿ 19 seconds later, at 12:55:51.When an alarm for the loss of the fetal heart rate (e.G., ¿fhr1 signal loss¿) happens, an audible and visual alarm appears on the screen.In case the audible alarm is acknowledged, it is silenced, but the visual alarm is still visible on the screen of the fetal monitor.The visible alarm only disappears once the signal gets recovered.Based on the information available and the testing conducted, the device was functioning as intended, and there was no trouble found with the device.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18527197
• MDR Text Key: 333486561
• Report Number: 9610816-2024-00020
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: 00884838000414
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/17/2024
• Is this an Adverse Event Report?: No
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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