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

Model Number M2703A

Device Problems Device Alarm System (1012); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).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 avalon fm30 fetal monitor stopped recording the heart rate.No alarm was triggered even though there was no printout.It is unknown if the device was in use monitoring a patient.The customer reported that an adverse event occurred.

Manufacturer Narrative

Philips received a complaint on the avalon fm30 fetal monitor indicating that the paper was ripping and the recording of the heart rate monitoring stopped without triggering a technical alarm.Good faith efforts (gfe) confirmed there was no harm or injury associated with the philips device.A philips field service engineer (fse) went onsite to perform functional tests.As the device documented in this complaint was not available for testing, a functional check was performed on a similar device not related to this complaint.The testing revealed that non-philips paper was used on that particular device.However, all functional tests that were performed were passed including the printing of the strip.As described in the instructions for use, users are advised to use the paper recommended by philips.The cause for the reported issue could not be confirmed.The testing of one unrelated unit and the printing of the strips passed during the field service engineer onsite visit.The reported problem could not be confirmed.As the device reported in this complaint was not available, the exact cause for the reported issue could not be determined.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : affected device not made available by customer for onsite testing by philips field service engineer.

Event Description

The customer reported that the printing paper was ripping on the avalon fm30 fetal monitor and the recording of the heart rate monitoring stopped without triggering a technical alarm.The device was in use monitoring a patient at the time of the reported issue.During the investigation it was confirmed that there was no harm or injury to the patient.

• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18190403
• MDR Text Key: 328778943
• Report Number: 9610816-2023-00615
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: 00884838000414
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: M2703A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2009
• 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