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

Model Number M2703A

Device Problems Protective Measures Problem (3015); Noise, Audible (3273)

Patient Problems Bradycardia (1751); Patient Problem/Medical Problem (2688)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested, not available at time of report.

Event Description

The customer reported that on the (b)(6) 2018, at 4:20 am the midwife noted that there was a noise disturbance in the monitor ,and after she replacing the us transducer ,the fetal heart rate (fhr) it was 40 beets per minute and bradycardic.The patient was connected to the avalon fm30 at that time after having taken a shower.The patient was transferred to a cesarean section.Since the baby was born with an apgar score between 1-6 the baby was transferred to the nicu.After a few days the babies condition improved.

Manufacturer Narrative

H3 and h6: the avalon fetal monitor, toco transducer and us transducers were tested in the hospital by their biomedical engineer and by the technical service manager.All devices were found to work as specified.The devices are back in use at the customer site.The provided trace for the reported event was evaluated by the philips research and development department (r&d).The provided trace indicates a time stamped 6:32-6:34 event where the avalon us transducer measured the maternal heart rate (mhr) instead of the fetal heart rate (fhr) ("switching to mother" artifact).The tested avalon fetal monitor, avalon us and toco mp transducers, which were found to perform to specification and as intended, are in use at the customer site.The customer was informed per letter (b)(6) 2020 about the investigation results.Although the devices worked as intended during the testing, a malfunction cannot be completely ruled out based on the information provided.The exact cause for the reported issue remains unknown.There is no indication that this failure could be difficult to detect.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.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 FM30 FETAL MONITOR
• Type of Device: FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7897207
• MDR Text Key: 120967245
• Report Number: 9610816-2018-00230
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (y/n): N
• PMA/PMN Number: K052795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2703A
• Device Catalogue Number: 862199
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other