MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. PHILIPS AVALON FM20 FETAL MONITOR; PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50

Model Number FQPH8820

Device Problems Erratic or Intermittent Display (1182); Electrical /Electronic Property Problem (1198); Misassembly by Users (3133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection identified that the warranty label had been compromised.Device evaluation identified that the fetal sensor compartment was open, the unit was missing the interfaces card, and the touch screen panel did not work.The touch screen assembly was replaced.The fetal sensor compartment was re-installed.The software was reloaded.The pcb (c73) was refurbished.The device was tested on a simulator.The root cause is most likely due to the device being opened by the customer; however, this cannot be confirmed.This type of reported event will continue to be monitored.It should be noted that this is being filed based on retrospective review.

Event Description

Reportedly, post repair, the fetal heart tones were showing to be in the 230's.It was noted that it was clear that the heart tones were not that high based on hearing them.The customer stated they had tried several different transducers with the same result.There was no report of patient harm.No additional event or patient information is available.

• Brand Name: PHILIPS AVALON FM20 FETAL MONITOR
• Type of Device: PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman rd.; andover MA 01810 1099
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 9618325
• MDR Text Key: 177826501
• Report Number: 3007409280-2020-00012
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FQPH8820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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