MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR

Model Number 865071

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 11/03/2021

Event Type  Injury  

Event Description

The customer reported that a baby had to be moved to resuscitation (resus) room.No additional information was provided and the patient outcome is unknown at this time.

Manufacturer Narrative

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

Manufacturer Narrative

Several attempts were made to gather additional information from the customer; however, no additional information was received.Patient outcome code and health impact code were corrected.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: AVALON FM50 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12818186
• MDR Text Key: 280805640
• Report Number: 9610816-2021-10493
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• 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