MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SERIES 50A ANTEPARTUM FETAL MONITOR

Model Number 862336

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

A philips response service engineer (rse) spoke to the customer and confirmed the caused of the device was a faulty speaker.The customer requested a quote for spare parts, however parts are no longer for the device as the device is obsoleted.

Event Description

It was reported, that the series 50a antepartum fetal monitor loudspeaker is defective.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: SERIES 50A ANTEPARTUM FETAL MONITOR
• Type of Device: SERIES 50A ANTEPARTUM 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: 18154702
• MDR Text Key: 328600771
• Report Number: 9610816-2023-00593
• Device Sequence Number: 1
• Product Code: HFM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K1217116
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862336
• Device Catalogue Number: 862336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2004
• 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