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

Model Number M2702A

Device Problems No Audible Prompt/Feedback (2282); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the patient came to the hospital for fetal heart monitoring at 37 weeks of pregnancy.The sound was sometimes absent during fetal heart monitoring, although the positioning was good.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

Philips received a complaint on the trackwise reporting system indicating that there was, no signal from the avolon transducer.The device was in use.There was no report of patient or user harm.The customer has elected to involve a third party supplier for any further issues with this device.No further action required.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

H3 other text : device sent to third party for evaluation.

• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15691816
• MDR Text Key: 302701810
• Report Number: 9610816-2022-00546
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: 00884838000407
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• 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: 09/29/2022
• 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