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

Model Number	M2703A
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1; reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).H6: a follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the screen is frozen, need to check tococardiograph.It is unknown if the device was in clinical use at time of event, no adverse event was reported.
Additional Manufacturer Narrative
After further investigation, it was determined that this case is not a reportable event with philips.Any failure related to the touch screen would be obvious to users because an incorrect response or lack of touch response is easily distinguished from normal response.During this time, physiological data can continue to be displayed, and alarms can continue to operate.The user would make arrangements for use of an alternate display as indicated.The field service engineer recalibrated the touch screen and did the necessary checks have been carried out to certify the correct operation of the equipment.This is deemed not a reportable event with philips.

• 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: 21138724
• Report Number: 9610816-2025-000034
• Device Sequence Number: 6957636
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/09/2025
• Date Device Manufactured: 01/13/2021
• 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