MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EARLYVUE VS30 VITAL SIGNS MONITOR

Model Number 863380

Device Problem Incorrect Measurement (1383)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting performed on the device was complete by the customer prior to them contacting philips.At the time of contact with philips, no additional device evaluation was performed as the customer requested replacement of the device's spo2 board assembly.The following part was sent to the customer for replacement: 453564792521,chl-vs philips spo2 bd assy - fs.The device remains at the customer site.

Event Description

Per the customer, "an spo2 card offset values with the simulator".Patient involvement is unknown.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).

• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12478516
• MDR Text Key: 271651877
• Report Number: 1218950-2021-10925
• 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,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2020
• 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