MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM20 FETAL MONITOR

Model Number M2702A

Device Problems Improper or Incorrect Procedure or Method (2017); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

A field service engineer (fse) went on-site to evaluate the device.The recorder block was checked and cleaned and an extended test and a calibration of the recorder was performed.A technical alarm for "end of paper" was simulated and a blue visual and audible alarm occurred.Furthermore the technical alarm "check paper" was simulated and a blue visual alarm was displayed.No trouble was found.Additionally a paper test of the third party paper was done by the fse and evaluated by research & development (r&d).During that test, the sensitivity of the paper and the page detection cell (black square) are measured.The test results showed, that the black marks and the values for the white area were in order.However, a ¿verify paper¿ note was printed, which is a sign that the fetal monitor is having issues with the paper and the paper should not be used.Based on the information provided and the evaluation results obtained, the issue was caused by user error, the device worked as intended and there was no malfunction of the device.No further investigation or action is warranted.

Event Description

The customer reported that "the cardiotocograph did not inform the user that the paper stopped running 09:00 am.The midwife analyzed the recording at 9:20 am, she did not see this stop and interpret the current layout as recent.It was only during her visit at 9:45 am that she became aware of the problem.Unfortunately, the condition of the baby was not good and the care of the baby was delayed.The recorder stopped running 1 ½ pages before the end of the paper.User could re-print the missing record afterwards.Customer did not use philips paper.The headnurse informed philips that there were neurological sequelae on the child".The baby suffered from neurological sequelae as a result of the reported event.

• Brand Name: AVALON FM20 FETAL MONITOR
• Type of Device: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9254915
• MDR Text Key: 164335787
• Report Number: 9610816-2019-00286
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2702A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2012
• 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
• Patient Outcome(s): Other