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

Model Number	863276
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting institution phone #: (b)(6).A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported inconsistencies in spo2 readings, sometimes the readings are high and sometimes they are low.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.
Additional Manufacturer Narrative
Section b event date was corrected.Section g date received by mfg (rfb) was corrected.
Additional Manufacturer Narrative
The customer contacted the customer care solutions center (ccsc) for assistance.Philips remote support (rs) provided customer a service repair quotation for the replacement of the spo2 board and nbp pump assembly.A service repair quotation has been provided to the customer.However, the customer has not accepted the quotation for repair.A search in salesforce found no further related calls.The device remains at the customer's facility.H3 other text : see h10.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Common Device Name: SURESIGNS VSI - NBP/SPO2
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13940112
• Report Number: 1218950-2022-00271
• Device Sequence Number: 6702278
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,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: 863276
• Device Catalogue Number: 863276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 01/06/2022; 05/31/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/12/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2015
• 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