MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM30 FETAL MONITOR

Model Number M2703A

Device Problems Circuit Failure (1089); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

It was reported that there was no sound although an error appear on the screen.The device was in use on a patient.There was no report of patient or user harm.

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 Description

The customer reported an avalon fm30 was displaying an error message and had no sound.The device was in use on a patient.There was no report of patient or user harm.The remote service engineer (rse) performed troubleshooting with the customer and confirmed the issue was a bus master malfunction.A philips field service engineer (fse) was sent onsite to replace the bus master board to resolve the issue.After the board was replaced the error message went away.

• Brand Name: AVALON FM30 FETAL MONITOR
• Type of Device: AVALON FM30 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15539662
• MDR Text Key: 301134331
• Report Number: 9610816-2022-00509
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: 00884838000414
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M2703A
• Device Catalogue Number: M2703A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1