MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR

Model Number	865071
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a customer site visit, the customer reported that they were unable to assess fetal heart status while a patient was being moved to the or during fetal distress.The patient was surgically delivered via caesarian section.The surgical delivery was a success, and there was no harm to the baby.The registered nurse (rn) stated that had the staff been able to continue monitoring the fetal heart, a surgical delivery may have been avoided.A philips clinical solutions implementation consultant (csic) spoke to the customer at the time of the site visit.The rn stated that at the time of the event the site was getting new fetal monitors (fm50, revision l) to replace all currently installed fetal monitors (fm50, revision g).The rn further stated that due to the monitors in the operating room (or) not being exchanged when the labor & delivery monitors were already exchanged, they were unable to assess fetal heart status.The csic was able to confirm that the or fetal monitors had already been upgraded to revision l at the time of the event.The csic states that there is a delay of approximately 10 seconds when connecting the toco+mp with a fetal spiral electrode attached to the fetal monitor.The delay may have led to the rn to believing that the device had malfunctioned.The csic tested the device and confirmed that there is a delay when connecting which could seem excessive during the emergency situation of fetal bradycardia.A philips clinical expert assessed the information provided and determined the following: as there are multiple ways to measure fetal heartrate, it not likely this short delay in monitoring was the reason for the caesarean section (c-section).This was a clinical decision made by the physician at the time of the event.No further investigation or action is warranted at this time.

• Brand Name: AVALON FM50 FETAL MONITOR
• Common Device Name: AVALON FM50 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15905857
• Report Number: 9610816-2022-00613
• Device Sequence Number: 20274341
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female