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

Model Number 863276

Device Problem Incorrect Measurement (1383)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting institution phone #: (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event 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.

Manufacturer Narrative

Section b event date was corrected.Section g date received by mfg (rfb) was corrected.

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
• Type of Device: 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
• MDR Text Key: 288175305
• Report Number: 1218950-2022-00271
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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
• 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
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 01/06/2022; 05/31/2022
• Supplement Dates FDA Received: 04/12/2022; 06/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2015
• 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