MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EARLYVUE VS30 VITAL SIGNS MONITOR

Model Number 863359

Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporting institution phone number:(b)(6).Reporter phone number: (b)(6).

Event Description

It was reported the device has a loudspeaker error.It is unknown if the device produced audible sound.It is unknown if the device was in clinical use at the time of the event.No adverse event or patient harm was reported.

Event Description

Philips received a complaint on the earlyvue vs30 vital signs monitor sn (b)(6) indicating loudspeaker error.The device was in clinical use.There was no patient or user harm reported.

Manufacturer Narrative

Diagnostic/functional testing was performed at the philips authorized repair facility.Results of the evaluation confirmed the reported issue.The speaker assembly was replaced to resolve this issue.No further action is needed at this time.Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).

• Brand Name: EARLYVUE VS30 VITAL SIGNS MONITOR
• Type of Device: EARLYVUE VS30 VITAL SIGNS MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18428563
• MDR Text Key: 331795924
• Report Number: 1218950-2024-00003
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863359
• Device Catalogue Number: 863359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• 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