MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VSI - NBP/SPO2

Model Number 863276

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

The customer called to request a quote for a speaker and stated that "the other" is dysfunctional.There was no further information provided by the customer.Additional information is being requested.There was no reported patient or user harm.

Event Description

The customer called to request a quote for a speaker and stated that "the other" is dysfunctional.There was no reported patient impact / injury.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: SURESIGNS VSI - NBP/SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11377779
• MDR Text Key: 233456375
• Report Number: 1218950-2021-10025
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (y/n): N
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863276
• Device Catalogue Number: 863276
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/11/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1