MAUDE Adverse Event Report: VITALCONNECT, INC. VITALCONNECT; VISTACENTER

Model Number VISTACENTER

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem Hypoxia (1918)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

According to initial reporter: "this is a pilot and is being used in parallel to manual collection of vital signs as a validation phase of the project, therefore there was no impact to patient care, increased monitoring required, or adverse outcomes." a software defect was identified as the root cause of this event, which meets the definition of a malfunction; therefore, a correction has been initiated.Notification to affected users was initiated on 05/21/2020.We anticipate completion of correction by end of may 2020.(b)(4).

Event Description

A healthcare provider noticed a patient had a lowered spo2 reading that should have triggered a vistacenter notification to the care team, but no notification was found.The patient's oxygen saturation recovered, but was significantly low, exposing the patient to potential hypoxia for a short window of time.

• Brand Name: VITALCONNECT
• Type of Device: VISTACENTER
• Manufacturer (Section D): VITALCONNECT, INC.; 224 airport pkwy.; ste. 300; san jose, ca
• Manufacturer (Section G): VITALCONNECT, INC.; 224 airport pkwy.; ste. 300; san jose, ca
• Manufacturer Contact: cynthia merrell ; 224 airport pkwy.; ste. 300; san jose, ca ; 8160287
• MDR Report Key: 10116393
• MDR Text Key: 194139730
• Report Number: 3010830833-2020-00001
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00850490007139
• UDI-Public: 00850490007139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/28/2020

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: VISTACENTER
• Device Catalogue Number: 6200
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: C3010830833-05292020-001
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 71