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

Model Number M2705A

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

Patient Problem Death (1802)

Event Date 10/10/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that between (b)(6) 2019 the end users were silencing a coincidence alarm in room g640.The baby that was delivered died.

Manufacturer Narrative

Philips was contacted for review of the alarm history of the avalon fetal monitor fm50, as the customer believed that end users were silencing alarms on the third party medical record charting system (obix).A field service engineer went onsite to evaluate the device, but the device in question was in use and could therefore not be evaluated.Philips requested further information to allow the evaluation of the reported issue.However, neither a trace for the time frame in question nor any additional information was provided by the customer.No further contact was established by the customer regarding the reported device and issue.The exact cause for the reported issue remains unknown.Due to the lack of available information, a malfunction of the device cannot be ruled out.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: 9294856
• MDR Text Key: 165556434
• Report Number: 9610816-2019-00297
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: (01)00884838000438
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2705A
• Device Catalogue Number: 865071
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death