MAUDE Adverse Event Report: SURESIGNS VS3 NBP, SPO2, REC

Model Number 863072

Device Problem Incorrect Measurement (1383)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the problem of spo2 not giving accurate readings.The device was not in clinical use at the time the reported issue was discovered.

Manufacturer Narrative

The customer contacted the customer care solutions center(ccsc) for troubleshooting/evaluation of the device.According to the tracking information provided by the customer, the device was sent to bothell, wa.The device could not be located.The cause of the issue could not be identified.If the device is located, the case will be reopened to update the investigation findings.H3 other text : device lost during shipment.

Event Description

The customer reported the problem of spo2 not giving accurate readings.The device was not in clinical use at the time the reported issue was discovered.

• Brand Name: SURESIGNS VS3 NBP, SPO2, REC
• Type of Device: SURESIGNS VS3 NBP, SPO2, REC
• MDR Report Key: 12423663
• MDR Text Key: 269860176
• Report Number: 8043836-2021-10013
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863072
• Device Catalogue Number: 863072
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/10/2021
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2008
• 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