MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER

Model Number	M2736A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.Reporting institution phone: unk.
Event or Problem Description
It was reported that the avalon fm30 fetal monitor is unreliable in capturing fetal heart rate and distinguishing it from maternal heart rate.The device was reported to be in use on a patient, an adverse event was reported.
Additional Manufacturer Narrative
The following functional tests and communications were performed: it was reported that the mother presented with concerns of no fetal movement.The nurses placed the patient on the monitor in the triage area prior to physician confirmation of fetal life via ultrasound.The fetal heart tracing displayed bradycardia between 110-120 bpm as per biomed.Subsequently, an ultrasound revealed fetal death.A philips field service engineer (fse) went onsite to test the device but found no malfunction.Additional information was provided to philips clinical and it was indicated that the mother presented with self-reported reduction in fetal movement and the fetal heartbeat could not be heard using a doppler.The patient was then connected to the monitor and the toco+ sensor was placed, revealing a base fetal heart rate (fhr) of 115 beat per minute (bpm) right below the belly button; however, the fhr could not be obtained on the left or the right.The patient indicated again there was no fetal movement, and after 13 minutes of monitoring, the mother was connected to spo2 sensor and a coincidence alarm was generated, indicating the fhr was actually the maternal heart rate (mhr).The physician examined the fetal tracing and performed an ultrasound examination, revealing fetal death.The monitors were removed from service.It was noted fetal life was not confirmed via ultrasound prior to putting the patient on the monitor.Based on this information, the monitor was obtaining mhr instead of fhr, but it also appeared fetal death had likely occurred prior to monitoring.Technical investigation results indicated that it was though fetal demise had occurred prior to the mother presenting to the hospital.It was also indicated the maternal heart rate had been captured the entire time and fetal heart rate was never captured.Based on this information, the device did not cause or contribute to the pre-existing fetal death.The investigation concludes that no further action is required at this time.

• Brand Name: AVALON US TRANSDUCER
• Common Device Name: AVALON US TRANSDUCER
• 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: 18933740
• Report Number: 9610816-2024-00154
• Device Sequence Number: 19978530
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: 00884838002722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/03/2024

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: M2736A
• Device Catalogue Number: M2736A
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 07/02/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/01/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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