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

Model Number M2703A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Loss Of Pulse (2562)

Event Type  Death  

Manufacturer Narrative

(b)(6).A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that "during the birth on (b)(6) 2019, there was no trace of the baby's heart rate for about 20 minutes.The heart rate of the mother was measured.The baby was resuscitated after birth, but died on (b)(6) 2019.

Manufacturer Narrative

A third party authorized by philips went on customer's site and evaluated the device.During the course of the evaluation no trouble was found.A signal loss was simulated and detected by the monitor.While testing it was found that the ultrasound (us) transducer worked as intended.Furthermore there was no telemetry signal issue found.The monitor configuration was gathered by the third party and forwarded to product support engineering and research & development (r&d) for further evaluation.The monitor configuration showed that the physiological alarms were turned on.The low fetal heart rate alarm limit was set to 90 beats per minute (bpm) and the high alarm limit was set to 170 bpm.The monitor configuration was set to audible latching off, which means that if an alarm is generated and the vital returns to normal, the device is silencing the alarm on it's own.The investigation showed that the device worked as intended and there was no malfunction of the device.This issue was caused by user error.The customer was provided with the evaluation results by letter.No further investigation or action is warranted.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9516077
• MDR Text Key: 172576286
• Report Number: 9610816-2019-00344
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838034242
• UDI-Public: (01)00884838034242
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2703A
• Device Catalogue Number: 866076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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): Death
• Patient Weight: 3