MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EARLYVUE VS30 VITALS MONITOR

Model Number 863380

Device Problem Insufficient Information (3190)

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

Event Date 07/15/2021

Event Type  malfunction  

Event Description

The customer reported that the screen is broken further to a fall.The device was not in clinical use at the time the reported issue was discovered.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 (cfn/fei # 1218950; 510k k190624).

Event Description

The customer reported that after a fall the screen is damaged.Patient involvement is unknown.No adverse event involving a patient or user was reported by the customer.

Manufacturer Narrative

It is not known how the device fell and no additional information if the device was attached to a roll stand or wall mount.Therefore, we are considering this to be a malfunction of cause unknown.To resolve the screen damaged, the brt replaced the front panel assembly, lcd assembly, and lcd metal frame assembly.The absence of further calls supports that the reported problem was resolved.The device remains in use at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure.

Manufacturer Narrative

This supplemental report is created with reference to mfg report with corrected information to update the manufacturing site.

Event Description

The customer reported that after a fall the screen is damaged.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 MEDICAL SYSTEMS; 3000 minuteman rd; nanshan district; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; nanshan district; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12245366
• MDR Text Key: 264067604
• Report Number: 1218950-2021-10748
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 190624
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/03/2021; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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