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

Model Number EARLYVUE VS30 VITAL SIGNS MONITOR

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

A philips remote service engineer (rse) spoke to the customer and determined that the device came out of its support base when the nurses equipped the device with consumables.The customer reported weakness in the device's closing system on its mounting base.The rse recommended replacement of the front facade.Based on the information available and the testing conducted, the cause of the reported problem was the mount.The reported problem was confirmed.The customer will be provided a replacement front assembly to resolve the issue.It has been concluded that no further action is required at this time.(b)(6).

Event Description

Philips received a complaint on the earlyvue vs30 vital signs monitor indicating the screen was broken when the device fell.The device was in clinical use at the time the issue was occurred.There was no adverse event or patient harm reported.

• 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: 18578879
• MDR Text Key: 333722950
• Report Number: 1218950-2024-00054
• 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,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: EARLYVUE VS30 VITAL SIGNS MONITOR
• Device Catalogue Number: 863359
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• 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