MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON

Model Number	M2736A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/24/2012
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer sent an email query regarding a field action in 2009 for philips avalon fetal monitors.This was in relation to a case regarding a baby who died in (b)(6) hospital in 2012.A newborn died when the device was used for monitoring during delivery at (b)(6) 2012.The incident took place in the hospital delivery room.
Additional Manufacturer Narrative
A baby died on (b)(6) 2012.The incident was not reported to philips at that time.The investigation determined that the customer requested assistance to clarify questions related to the field safety notice from 2009 concerning the ultrasound (us) transducer signal ( i.E.Device detecting the fetal heart rate (fhr) ).This complaint is registered on the us transducer as the doppler echoes are processed by the mainboard within the ultrasound transducer by an auto-correlation algorithm to determine fetal heart rate (fhr).The signal processing of the fhr is done by the firmware (software) on the transducer mainboard.The fhr is only reported on the monitor¿s numeric display and on the recorded trace.The full traces of the incident have been provided by the (b)(4) to philips for an evaluation by product support engineering (pse) and a clinician.Pse stated that the traces show that the customer used multiple devices during that patient monitoring episode.A philips physician and an external midwife assessed the traces and concluded the following: the trace shows fetal distress starting at 06:32 am.From that moment onwards, the fhr trace rarely shows signals from the fetus, and is instead almost exclusively showing a maternal signal.This phenomenon is well-known and inherent to the fetal monitor¿s ultrasound technology.Therefore, the fetal monitor is designed to compare a known maternal signal (e.G.Pulse measured by an spo2 finger sensor) with the ultrasound signal.This coincidence analysis is continuously done by the monitor and alerts the user in case of a coincidence.Here, the coincidence analysis was only intermittently possible because the maternal spo2 probe was not used continuously after epidural anesthesia was started.However, during those periods when the spo2 sensor was applied to the mother, the fetal monitor issued multiple coincidence alerts consistent with its design and labeling.The strips provided to philips show no indication of device malfunction.The investigation reveals that there is no relation between the death on (b)(6) 2012 and the field actions from 2009.The traces provided to philips show no indication of a device malfunction.The products remain at the customer site.The provided information shows that all avalon devices involved in the incident had the latest firmware on (b)(6) 2012.This complaint does not represent a product/part failure.No further investigation or action is warranted.

• Brand Name: ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON
• Common Device Name: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7233465
• Report Number: 9610816-2018-00035
• Device Sequence Number: 17000128
• Product Code: HGM
• Combination Product (Y/N): N
• PMA/510(K) Number: K062137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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
• Operator of Device: Health Professional
• Device Model Number: M2736A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death