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

Model Number 863279

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/17/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

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
• Type of Device: 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 ; 7031463203
• MDR Report Key: 14089744
• MDR Text Key: 289254543
• Report Number: 1218950-2022-00332
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2015
• 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