MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITAL SIGNS MONITOR

Model Number 863359

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 03/22/2023

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 the earlyvue vs30 vital signs monitor displays a speaker malfunction.The presence of audio is not confirmed.Patient involvement is unknown.There was no report of patient or user harm.

Manufacturer Narrative

During investigation the reported problem turned out to be not reportable.Despite the speaker malfunction inop error message was displayed it was confirmed that the device still had sound.A speaker malf inop was reported as a visual message.The presence of a visual inop indicating that the speaker has malfunctioned when audio is confirmed to be operational and sound is provided is not likely to lead to harm as alarms continue to be annunciated.

• Brand Name: EARLYVUE VS30 VITAL SIGNS MONITOR
• Type of Device: EARLYVUE VS30 VITAL SIGNS 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: 16644817
• MDR Text Key: 312366044
• Report Number: 1218950-2023-00171
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190624
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 863359
• Device Catalogue Number: 863359
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 05/09/2023
• 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