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 02/10/2022

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 display is distorted and the parameters cannot be modified.The touchscreen seems to be frozen.The device was not in use on a patient at the time of event, there was no patient involvement.

Manufacturer Narrative

A philips field service engineer (fse) was dispatched on-site to evaluate the reported issue.Philips fse found that the screen was locked and the transducers could not be recognized.During the investigation of the issue philips fse found faulty main board.The main board was replaced.The device remains at the customer site.

• 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: 13693260
• MDR Text Key: 286758665
• Report Number: 9610816-2022-00117
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: 00884838000407
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 03/08/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2011
• 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