MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM30; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON FM30 FETAL MONITOR
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the vct (short term variation) results are inconsistent and too high.The device was not in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) contacted the customer regarding the reported vct (short term variation) results being inconsistent and too high.The rse discussed the following points with the customer.The technical information related to the vct has been explained.The monitor configuration has been verified and validated.The monitor does have the l3 revision with the c71 option enabled.The following software options are present and active: c71, yrd, cl1, cl2, cl3.The rse also explained that the ctv is an objective indicator of fetal variability, calculated automatically by the fm30.The calculation principle and conditions are as follows: calculation principle: the rcf is divided into 3.75-second segments.For each segment, the variation in the interval between two beats is calculated.An average of these variations is then carried out.The result is expressed in milliseconds (ms).Calculation conditions: continuous recording of at least 10 minutes.Automatic reassessment every 2 minutes.The ctv is a numerical value that is independent of the visual analysis of the plot.The higher the ctv, the more satisfactory the fetal variability is considered to be.Furthermore, the rse advised the customer that the fm30 fetal monitors are based on the dawes/redman algorithm.The rse sent a follow up email requesting additional information and inquiring if the associated sensors were tested in accordance with philips technical documentation.The rse has tried to reach out by phone in order to clarify the customer's request and confirm if they would like to set up an on-site intervention at the customer's site, but the customer has not responded to any attempts.The rse did clarify that the avalon sensor is suspected to be faulty, but that was not confirmed.The serial number for the avalon sensor was not provided.The avalon sensor is suspected to be faulty, but this could not be confirmed.Several attempts were made to contact the customer for a follow up, but the customer has not responded to any attempts and the case was closed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporting institution phone # (b)(6).

• Brand Name: AVALON FETAL MONITOR FM30
• Common Device Name: SYSTEM, MONITORING, PERINATAL
• 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: 24161060
• Report Number: 9610816-2026-100128
• Device Sequence Number: 9000654
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 01/23/2026

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: AVALON FM30 FETAL MONITOR
• Device Catalogue Number: 862199
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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