MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM20 FETAL MONITOR

Model Number M2702A

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

Patient Problem Death, Intrauterine Fetal (1855)

Event Type  Death  

Manufacturer Narrative

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

Event Description

In this case the customer reported a patient incident with a deceased fetus where it is now in question if the customer might have mistook the maternal heart rate as a fetal heart rate.

Manufacturer Narrative

Further information was requested.Unfortunately, the customer provided insufficient information (for example the trace and the sn# of the device are not available for investigation) and did not provide the requested information.For clear problem evaluation, the trace would have been needed.The toco mp transducer could not confirm the problem with the test of atom medical.What exact was tested is not known.It remains unknown how the problem was solved since the customer has refused to provide further information.Thus this case has insufficient information for a clear conclusion.Atom medical has tested the device and was not able to find any trouble with the device.The device remains at the customer site.In addition please note, the customer did not allege that the device was a factor.Investigation of this complaint supports that there is no design, manufacturing or materials problem, supporting that any further investigation or corrective or preventive action is warranted.

• Brand Name: AVALON FM20 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: wendy chadbourne ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6197914
• MDR Text Key: 63071675
• Report Number: 9610816-2016-00332
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2702A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 1 DA