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

Model Number 863380

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem High Oxygen Saturation (2478)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that saturations (spo2) are very high, usually measuring saturations of 100%.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: EARLYVUE
• Type of Device: EARLYVUE VS30 VITALS MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11076965
• MDR Text Key: 224597220
• Report Number: 9610816-2020-00473
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00884838075900
• UDI-Public: (01)00884838075900
• Combination Product (y/n): N
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863380
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1