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

Model Number	M2703A
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/13/2017
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 reported that the (b)(6) monitor did not warn clearly enough of a coincidence and the printout was misleading or unclear.A newborn died when the device was used for monitoring during delivery.
Additional Manufacturer Narrative
The customer stated that the warnings for a questionable fetal heart rate (fhr) were unclear to him, however, he suspected that the maternal heart rate (mhr) had been measured instead of the fhr.The customer complained that the monitor behavior is not clear and not sufficiently described in the instructions for use (ifu).According to the customer¿s problem description, the issue happened in the night from (b)(6) 2017.However, it was then determined based on the provided cardiotocograph (ctg) printout that the delivery took place in the night from (b)(6) 2017.The baby died on (b)(6) 2017.The service distributor was onsite to evaluate the reported issue and confirmed that no malfunction of the device was identified.Nevertheless, the biomedical engineer of the hospital sent the monitor to the philips factory for an additional evaluation.The returned device was checked by product support engineering (pse) who confirmed that the monitor successfully passed the final test.The logs of the monitor showed coincidence alarms at the time of the reported incident which were silenced manually by a user.By silencing alarms, the user acknowledges all active alarms by switching off audible alarm indicators.Pse confirmed that the device showed no malfunction and worked as specified.The customer was instructed about the intended functionality which is considered as all that is warranted for this issue.The product remains at the customer site and is still in use in the labor and delivery ward.Additionally, the available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.

• Brand Name: AVALON FM30 FETAL MONITOR
• Common Device Name: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7063061
• Report Number: 9610816-2017-00372
• Device Sequence Number: 1293504
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• PMA/510(K) Number: K052795
• 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): 11/23/2017

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: Physician
• Device Model Number: M2703A
• Device Catalogue Number: 862199
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 02/26/2018
• 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