MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC 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 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the front panel is broken after a fall.Patient involvement is unknown.There was no report of patient or user harm.

Event Description

The customer reported that the front panel is broken after a fall.There was no reported patient or user impact.

Manufacturer Narrative

This complaint was considered to be potentially reportable.It was reported conservatively due to additional information not received at the time of the reporting due date.Later, additional information received that the roll stand part number 989803144001 provided was not listed as an approved roll stand for this device.The ifu instructs the users which accessories are approved for use and also to inspect the monitor and accessories for deterioration or damage.The record was reviewed and re-evaluated to pose no health or safety risk to patients, users, or bystanders.No death, serious injury or adverse event was reported to have occurred or was alleged as a result of this issue.Based on this information provided, this will be considered non-reportable.

• Brand Name: EARLYVUE VS30 VITAL SIGNS MONITOR
• Type of Device: EARLYVUE VS30 VITAL SIGNS MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12882353
• MDR Text Key: 281323460
• Report Number: 1218950-2021-11136
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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