MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS2+ NBP/SPO2/WIRELESS

Model Number	863279
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported inaccurate spo2 readings.The device was not in use on a patient at the time of event, there was no patient involvement.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
After further review of the complaint and additional information obtained: the complaint is deemed non-reportable.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.The customer reported that they were unable to obtain an spo2 measurement.No patient harm has been alleged or is expected.The available information does not support that this failure mode would be difficult to detect.In this scenario, the user expected the device to produce a vital sign reading, but the device did not produce any reading.Additionally, a failure to perform measurements would generate an inop message and alarm tone that would alert users to a problem.If the malfunction were to recur, the user is likely to utilize alternative monitoring processes in place of the reported defective vital sign parameter in order to monitor the patient.Alternatively, the user may switch to a back-up monitor.If a back-up monitor was unavailable and lack of a back-up monitor was to preclude the use of the scanning device in diagnosis, alternative diagnostic methods would be implemented as warranted for the patient.As per the definition of non-reportable, this device/product issue did not cause or contribute to death or serious injury nor would likely cause or contribute to death or serious injury upon recurrence.

• Brand Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Common Device Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 14089744
• Report Number: 1218950-2022-00332
• Device Sequence Number: 4908330
• Product Code: DSK
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2015
• 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