MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM20 FETAL MONITOR

Model Number M2702A

Device Problems Defective Alarm (1014); 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  Injury  

Manufacturer Narrative

E1: reporter institution phone number (b)(6).E1: reporter phone (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the heart rate monitoring recording stops.The paper cuts, there is no more printout, but no alarm is triggered.Patient / user harm was reported without further details.

Event Description

It was reported that the paper was ripping 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.

Manufacturer Narrative

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 philips received a complaint on the avalon fm20 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.

• Brand Name: AVALON FM20 FETAL MONITOR
• Type of Device: AVALON FM20 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: 18184452
• MDR Text Key: 328697449
• Report Number: 9610816-2023-00607
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: 00884838000407
• 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 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: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2702A
• Device Catalogue Number: M2702A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2015
• 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