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

Model Number M2703A

Device Problem Defective Alarm (1014)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).

Event Description

The customer reported there is no alarm detected on the central station.Patient involvement is unknown.There was no report of patient or user harm.

Manufacturer Narrative

The remote service engineer (rse) sent a quote for onsite services, but the quote was not accepted by the customer.Based on the information available the cause of the reported problem is unknown, because the device was not evaluated by a field service engineer (fse) onsite nor was the device sent in for analysis and repair.A good faith effort was made to obtain additional information but no additional information could be retrieved.It is unknown if the device is back in service due to insufficient information.

• 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: 16662179
• MDR Text Key: 312494320
• Report Number: 9610816-2023-00144
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: 00884838000414
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 04/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2013
• 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