MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM30 FETAL MONITOR

Model Number M2703A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the ecg value is displayed continuously, even when removed from patient.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

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 FM30 FETAL MONITOR
• Type of Device: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10612091
• MDR Text Key: 209559414
• Report Number: 9610816-2020-00355
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (y/n): N
• PMA/PMN Number: K052795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2703A
• Device Catalogue Number: 862199
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1