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

Model Number 863380

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that there was no sound from speaker.Patient involvement is unknown.There was no report of patient or user harm.The earlyvue vs30 vitals monitor (model number 863359) is substantially similar to the earlyvue vs30 vitals monitor (model number 863380) and will be reported in the united states under device model number 863380.

Manufacturer Narrative

The customer contacted the customer care solutions center(ccsc) for troubleshooting/evaluation of the device.The customer replaced the speaker but the problem persists.To resolve the issue, the customer replaced the main board.

Event Description

The customer reported that there was no sound coming from the speaker.Patient involvement is unknown.No adverse event involving a patient or user was reported by the customer.

Manufacturer Narrative

This supplemental report is created with reference to mfg report #1218950-2021-10644 with corrected information to update the manufacturing site.

Event Description

The customer reported that there was no sound coming from the speaker.Patient involvement is unknown.No adverse event involving a patient or user was reported by the customer.

• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 11996580
• MDR Text Key: 256116040
• Report Number: 1218950-2021-10644
• 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: Other
• Type of Report: Initial,Followup,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?: No
• Distributor Facility Aware Date: 05/31/2021
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 05/31/2021; 05/31/2021
• Supplement Dates FDA Received: 08/04/2021; 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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