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

Model Number 865071

Device Problem Insufficient Information (3190)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

Customer reported an unspecified request to replace the loudspeaker assembly.There was no patient harm or injury reported.

Manufacturer Narrative

After further information was received, this record will now be considered non reportable.H3 other text : no alleged failure.

Event Description

Customer reported an unspecified request to replace the loudspeaker assembly.Patient involvement is unknown.There was no report of patient or user harm.The customer contacted philips customer care to order parts, including a speaker assembly.At the time there was no documentation why the parts were being ordered.After gfe attempts were made with no response, a new case was created where it was documented the customer stated the parts were ordered for stock only.After further information was received, this record will now be considered non reportable.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15396655
• MDR Text Key: 301157931
• Report Number: 9610816-2022-00488
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2014
• 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