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

Model Number	VISTACENTER
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: VISTACENTER
• Manufacturer (Section D): VITALCONNECT, INC.; 224 airport pkwy.; ste. 300; san jose, ca
• MDR Report Key: 10116393
• Report Number: 3010830833-2020-00001
• Device Sequence Number: 3622606
• Product Code: DRG
• UDI-Device Identifier: 00850490007139
• UDI-Public: 00850490007139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall,Notification,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: VISTACENTER
• Device Catalogue Number: 6200
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: C3010830833-05292020-001
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 71