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	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following communications were performed: a philips remote service engineer (rse) spoke with the customer and the customer informed that the device produced no sound even after the loudspeaker was replaced.The device also only reported a speaker malfunction once, but that message was not repeatable.The rse suggested to the customer to replace the 451261025111, api board as the api [all peripheral interfaces] board incorporated an audio amplifier which controlled the loudspeaker.The cause of the reported problem was due to a defective api board.The reported problem was confirmed.The customer was taking responsibility for servicing the device.The customer had been notified to contact philips for any follow up at which point a new service order would be created, if applicable.
Event or Problem Description
The customer reported that there was no audio, even after loudspeaker replacement.The device was not in use on a patient at the time of the event.There was no adverse event reported.

• 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: 19461757
• Report Number: 9610816-2024-00310
• Device Sequence Number: 20814673
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/04/2024

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: 865071
• 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: 05/30/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2012
• 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