AVALON FM30 FETAL MONITOR M2703A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for AVALON FM30 FETAL MONITOR M2703A manufactured by Philips Medical Systems.

Event Text Entries

[130498399]
Patient Sequence No: 1, Text Type: N, H10

[130498400] The customer reported "no alarm for a low fetal heart rate (fhr) on (b)(6) 2018". The device was in use on a patient at the time of the reported issue. No death, or patient/user injury or harm was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610816-2018-00351
• MDR Report Key: 8163983
• Date Received: 2018-12-14
• Date of Report: 2018-11-16
• Date Mfgr Received: 2018-11-16
• Device Manufacturer Date: 2016-01-22
• Date Added to Maude: 2018-12-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. ROBERT CORNING
• Manufacturer Street: HEWLETT-PACKARD STR.2
• Manufacturer City: BOEBLINGEN 71034
• Manufacturer Country: GM
• Manufacturer Postal: 71034
• Manufacturer G1: PHILIPS MEDICAL SYSTEMS
• Manufacturer Street: 3000 MINUTEMAN ROAD
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal Code: 01810
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: AVALON FM30 FETAL MONITOR
• Generic Name: FETAL MONITOR
• Product Code: HGM
• Date Received: 2018-12-14
• Model Number: M2703A
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-14