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

Model Number 863380

Device Problem No Audible Alarm (1019)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

The customer reported that the speaker on their vs30 monitor was malfunctioning.The device was not in clinical use when the issue was discovered.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

Problem statement: the customer reported speaker malf - the monitor in fact has no audio.There was no reported patient impact / injury.Complaint evaluation: biomed states vs30 continuous speaker malfunction.Reinstalled latest software speaker malfunction inop still present.Customer already replaced speakers.Customer resolution and conclusion the device sent to bench for repair.Bench tested device and produced sound-reset speaker to fix issue, passed internal inspection.Calibrated nbp assy and touchscreen.Passed all pa tests.No other issues found.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.No further action or investigation is warranted based on the available information at the time of complaint closure.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? no was there any adverse event to the patient or user? if yes, describe? no if there was an adverse event, did the device cause or contribute to the adverse event, and how? there was no adverse event or patient harm reported.

• Brand Name: EARLYVUE VS30 VITALS MONITOR
• Type of Device: EARLYVUE VS30 VITALS 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15747741
• MDR Text Key: 303298402
• Report Number: 9610816-2022-00566
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other Health Care Professional
• 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: 863380
• Device Catalogue Number: 863380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/24/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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