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

Model Number	M2736A
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
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 that no sound was generated when trying to determine fetal heart rate despite the volume being set to maximum.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
Additional information received indicating the transducer was faulty.This is no longer considered a reportable event.Failure to measure ultrasound would be detectable by the user and would prompt the clinician to use alternative methods of monitoring or to troubleshoot the monitor.As part of a fundamental use model for this device to monitor the fetal heart rate (fhr) using ultrasound, it is necessary for the clinical staff to locate the fetal heart using sound generated by the ultrasound transducer.A defect transducer would in addition not provide a fetal heart rate.As part of a fundamental use model for this device to evaluate the trace for suspicious trace patterns.A trace pattern is the conjunction between the fetal heart rate and the contractions.A missing fhr would be immediate obvious.

• 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: 20063790
• Report Number: 9610816-2024-00550
• Device Sequence Number: 8826507
• Product Code: MHX
• UDI-Device Identifier: 00884838002722
• UDI-Public: (01)00884838002722
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110622
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: M2736A
• Device Catalogue Number: M2736A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown