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

Model Number	M2703A
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following functional tests were performed: the fields service engineer (fse) went onsite to evaluate the device in question.It was stated the system has been experiencing intermittent dropouts.The customer the wi-fi was recently updated, which might suggest environmental interference as a potential cause.Due to the room being occupied and the patient actively in labor, i was unable to access the device for an extended period.However, from my observations, the device appeared to be operating without issues.With that the fse changed the settings after conducting an obr scan, the fse change room 8 from channel 9 to channel 11.Room 7 remains on channel 8.This adjustment creates a larger gap between rf channels, particularly as the most affected areas are room 7 and room 8.This information was given to the customer and requested monitoring of the device over a period of time to determine if the issue persists.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer reported the fetal monitoring is losing transducer signal approximately every ten seconds and when it came back the heart rate was high and then would drop.The user swapped the us transducers as the signal was not picking up; however, even though the us transducer was docked, the fm30 was still picking it up and had not removed it from screen.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
E1; reporter institution phone number (b)(6).E1: reporter phone number: (b)(6).A follow up report will be submitted once the investigation is complete.

• Brand Name: AVALON FM30 FETAL MONITOR
• Common Device Name: 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 ; 70314632031
• MDR Report Key: 20834605
• Report Number: 9610816-2024-000929
• Device Sequence Number: 19799498
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M2703A
• Device Catalogue Number: M2703A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown