MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2

Model Number 863276

Device Problem No Audible Alarm (1019)

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

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported speaker malfunction from the device.It is unknown if the device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

H3 other text: customer refuses service.

Event Description

The customer reported that a speaker malfunction inops was displayed, no sound was coming from the device.The device was in use at time of event, there was no adverse event reported.Philips contacted the customer for service, but the repair was refused by the customer.The cause remains unknown.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: SURESIGNS VSI - NBP/SPO2
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16120449
• MDR Text Key: 307903098
• Report Number: 1218950-2023-00012
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2017
• 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