MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM30 FETAL MONITOR

Model Number M2703A

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Intermittent Communication Failure (4038)

Patient Problem Unspecified Reproductive System or Breast Problem (4513)

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the system fetal wireless system has failed unnecessary c-sections.The device was in use at the time of the event.There was no harm to the patient or user, but resulted in an unexpected result for the patient.

Event Description

Philips received a complaint from a customer carteret health stating that as a result of their philips devices being down, and a delay in getting replacement parts, they have experienced increased rates of cesarian section births, and increased readmission rates as a result of the increased cesarian section procedures.The customer states that this has resulted in not meeting joint commission requirements or leapfrog goals.The customer has established alternative means of monitoring via a cabled ultrasound transducers during procedures.No philips device was reported to have been in clinical usage during the cesarian procedures or any other adverse event.The devices were not in clinical usage during any reported event and therefore no investigation is applicable.The device failures are not related to any reported adverse event.Evidence was provided that there were 4 devices, 2 wireless systems total, that were awaiting part orders.The alleged device failures are being investigated within complaint records.A philips senior research and development manager and clinical specialist reviewed the statement from the customer regarding the increase in c-sections procedures.The philips senior research and development manager and clinical specialist stated the following: studies have indeed indicated that patient mobility and ambulation are beneficial for the patient comfort, modus of birth, episiotomy rates, need of pain medication, and ultimately for the labor progress.Nonetheless, state of the art fetal monitoring is not only possible using wireless transducers, but also with wired transducers, which are still standard in many hospitals.Also, according to a cochrane review there was not a correlation of c-section rates with an epidural anesthetic (that more or less immobilizes the patient).A clinical assessment was performed and determined the following: reassessment was performed based on new information received in the record.Upon review, it was noted that alternative methods of fetal monitoring were used, specifically cabled transducers.The following statement was taken from an r&d response to the allegation of increase c-section rates at this facility "studies have indeed indicated that patient mobility and ambulation are beneficial for the patient comfort, modus of birth, episiotomy rates, need of pain medication, and ultimately for the labor progress.Nonetheless, state of the art fetal monitoring is not only possible using wireless transducers, but also with wired transducers, which are still standard in many hospitals." based on limited information available and the fact that the facility used cabled transducers to monitor fetal heart rate, it remains unknown what contribution, if any, the lack of availability of philips wireless transducers may have had on hospital c-section rates.If additional information is obtained, please request reassessment of the record by the pms clinical expert.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The engineer provided their analysis findings however we are unable to confirm the final disposition of the devices because they will be investigated individually.This complaint was a general dissatisfaction about philips service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Sources: 1) cochrane review: anim-somuah m, smyth rmd, cyna am, cuthbert a.Epidural versus non-epidural or no analgesia for pain management in labour.Cochrane database of systematic reviews 2018, issue 5.Art.No.: cd000331.Doi: 10.1002/14651858.Cd000331.Pub4 2) nice guideline, published: 31 march 2021, www.Nice.Org.Uk/guidance/ng192 , ¿1.3 factors affecting the likelihood of emergency caesarean birth during intrapartum care.¿ h3 other text : the devices were not in clinical usage during any reported event and therefore no investigation is applicable.

• Brand Name: AVALON FM30 FETAL MONITOR
• Type of Device: AVALON FM30 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: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16410941
• MDR Text Key: 309975119
• Report Number: 9610816-2023-00093
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: 00884838000414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M2703A
• Device Catalogue Number: M2703A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention