MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM50 FETAL MONITOR; PERINATAL MONITORING SYSTEM

Model Number M2705A

Device Problems Improper or Incorrect Procedure or Method (2017); Human-Device Interface Problem (2949)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer asked how to prevent a user from turning off spo2 alarms.The device was used for monitoring at the time of the alleged malfunction.A female patient required oxygen delivery to get the saturation back to a normal range.

Manufacturer Narrative

According to the clinical support engineer (cse) who evaluated this issue, the customer stated that they want to be able to prevent any user from turning off the spo2 alarm on the fetal monitor (fm).The customer reported that they had a patient who was hypoxic for 6 hours and they confirmed that a user turned off the spo2 alarm.Therefore there were no alarms for a low spo2 measurement for that patient.The user wants to prevent this from happening again.The issue was evaluated by product support engineering (pse) who confirmed that the sp02 alarm can be deactivated by the user without entering a password.The deactivation of the alarm could not be restricted by design.However, if a user deactivates an alarm, this will only be applicable for the current monitoring episode.A new patient monitoring episode will have the default configured alarm setting.According to given information, no malfunction of the device could be identified.The provided information shows that the device works as specified.The customer was instructed about the alarm functionality.An enhancement request was addressed to product marketing.The issue was not caused by a malfunction of the device.No further investigation or action is warranted.Patient information requested, not available at time of report.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: PERINATAL MONITORING SYSTEM
• 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: 7291673
• MDR Text Key: 100762594
• Report Number: 9610816-2018-00050
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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): Required Intervention