MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM50

Model Number	AVALON FM50 FETAL MONITOR
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2025
Type of Reportable Event	Death
Additional 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 or Problem Description
It was reported the tracings generated via the wireless transducer intermittently dropped out while fetal decelerations were occurring, which resulted in the patient being transported to another hospital; however, the customer indicated they did not believe the monitor issue contributed to the patient condition.The staff changed to wireless monitoring due to this issue and indicated this labor and delivery room is the only room experiencing this issue.It was also noted the hospital uses ge centricity for central monitoring.Based on this information, the fetus exhibited decelerations while there were signal dropouts, which the customer does not believe was due to the dropouts; however, the type of reported complaint was marked as death.
Additional Manufacturer Narrative
A good faith effort (gfe) was made to get additional information about the patient, but the customer did not share any more information.A philips field service engineer (fse) evaluated the device and was unable to confirm cause of the reported tracing dropouts.The customer decided to use only hardwire transducers as there seemed to be some sort of intermittent outside interference that could not be determined.Based on the results of the analysis, the product malfunction was unable to be confirmed.As for precautionary measures the obr channels were changed, and the customer switched to hardwire transducers and was informed to call back if the issue still persists.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: AVALON FETAL MONITOR FM50
• Common Device Name: AVALON FETAL MONITOR FM50
• 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: 22978131
• Report Number: 9610816-2025-000816
• Device Sequence Number: 18499290
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: (01)00884838000438
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVALON FM50 FETAL MONITOR
• Device Catalogue Number: 865071
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown