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

Model Number EARLYVUE VS30 VITAL SIGNS MONITOR

Device Problems Display or Visual Feedback Problem (1184); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A follow up report will be submitted once the investigation is complete.

Event Description

It was reported that the system hangs during measurement.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

The device was sent to philips bench repair.The bench repair technician (brt) found that the device would hang occasionally and determined that the main board required replacement.The brt replaced the main board and performed the stk and function check, and the device passed.The device was operational after replacing the main board was completed.

• 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: 17390866
• MDR Text Key: 319934409
• Report Number: 1218950-2023-00516
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• 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: Foreign,Health Professional
• 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: 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: 06/29/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2020
• 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