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

Model Number	863277
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer(fse) went to the customer site.Fse could not confirm the customer's reported issue.Fse informed the customer to ensure they are using the recommended philips accessories and consumables.Issue was not confirmed and no repairs were performed.The device is working according to specifications.Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).
Event or Problem Description
The customer reported the spo2 measurement was reading 4 points higher than it actually was measuring.The device was in use.There was no patient or user harm reported.

• Brand Name: SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS
• Common Device Name: SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS
• 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: 18346015
• Report Number: 1218950-2023-00942
• Device Sequence Number: 6222457
• Product Code: DXN
• UDI-Device Identifier: 00884838028388
• UDI-Public: 00884838028388
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 863277
• Device Catalogue Number: 863277
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown