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

Model Number M2705A

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the fetal monitor did not alert for a bradycardia condition.There was no adverse event.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 8968883
• MDR Text Key: 176951730
• Report Number: 9610816-2019-00226
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K071800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2705A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1