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

Model Number	865071
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was a loudspeaker failure.Audio has not been confirmed.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
Visual inspection showed that the front panel is broken and the printer mechanics are loose.Functional testing indicated that there was a loudspeaker error.Replacement of loudspeaker was unsuccessful.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
During follow up interviews, the customer reported there was a loudspeaker error, however, audio was functioning as expected.The field service engineer(fse) confirmed the loudspeaker error.Replacing the loudspeaker did not resolve the issue.The fse determined the power supply of the loudspeaker was insufficient.The fse replaced the api board to resolve the issue.Unit is now working according to specifications.
Event or Problem Description
The customer reported a loudspeaker error is displayed.The device was in use at the time of the event.There was no report of patient or user harm.

• Brand Name: AVALON FM50 FETAL MONITOR
• Common Device Name: AVALON FM50 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: 18069987
• Report Number: 9610816-2023-00562
• Device Sequence Number: 7665143
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup

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
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2012
• 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