MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM20 FETAL MONITOR

Model Number M2702A

Device Problem Image Display Error/Artifact (1304)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the avalon fm20 fetal monitor freezes and stops printing.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Manufacturer Narrative

The biomed reported that the avalon fm20 fetal monitor keeps freezing and it stops printing, the display goes out, but the unit does not shut off.When the display comes back on it is on the patient screen (stale data) not the start up screen.The device was sent in to bench repair for further evaluation.During bench repair it was found that the main board was faulty and needed to be replaced to resolve the reported issue.The problem was resolved by replacing the min board.The repaired device was returned back to the customer's facility.

• Brand Name: AVALON FM20 FETAL MONITOR
• Type of Device: AVALON FM20 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14492007
• MDR Text Key: 292606892
• Report Number: 9610816-2022-00295
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: 00884838000407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2702A
• Device Catalogue Number: M2702A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2011
• 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