MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Sweating (2444); Low Oxygen Saturation (2477)

Event Date 01/03/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2021 date of report: 15jan2021.

Event Description

A customer reported to philips that while receiving high flow therapy from the respironics v60 ventilator, a patient experienced an event of oxygen desaturation, tachycardia, and diaphoresis.Hospital staff was not able to place the v60 into standby mode and change the therapy, the patient required endotracheal tube placement and mechanical ventilation.The customer reported that the unit was in use on a patient at the time of the reported device behavior and reported adverse events.

Manufacturer Narrative

G4:22jan2021.B4:28jan2021.The hospital's biomedical engineer evaluated the device.The reported issue was confirmed and traced to a faulty flow sensor.No error codes were reported.The biomedical engineer was not able to provide a copy of the diagnostic report.The biomedical engineer replaced the flow sensor.The device passed all performance verification tests and was returned to the customer.This reporter stated that a 66 years old male patient with a weight of 275 pounds and a height of five feet three inches, weight was admitted to a hospital¿s intensive care unit (icu) on an unknown date with the admitting diagnosis of coronavirus (covid-19).Relevant medical history included: hypertension, obstructive sleep apnea, atrial fibrillation, and obesity.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed high flow therapy via the respironics v60 ventilator with software version 3.0; 75 liters per minute, 95% fraction of inspired oxygen (fio2), a philips high flow nasal cannula ac611 medium size, 22 millimeter circuit, and a fisher & paykel mr850 respiratory humidifier.While admitted on (b)(6) 2021, the patient was receiving high flow therapy therapy via the v60 device, when he experienced an event of decreased peripheral capillary oxygen saturation (spo2) to the mid 70s, tachycardia with a heart rate in the 110s, and diaphoresis.Hospital staff then attempted to change the mode of the v60 ventilator to bi-level positive airway pressure (bipap), placed a mask and circuit on the patient; brand and model not reported, then pressed standby and then ventilation on two occasions, but the therapy was not transitioned from high flow therapy to non-invasive ventilation.Hospital staff then turned the v60 off, then back on, but would not go into ventilation mode.Hospital staff then returned the patient to high flow therapy and the patient¿s spo2 stayed in the 70s with an oxymask at 15 over the cannula.The patient then experienced an event of tachycardia with a heart rate of greater than 150 beats per minute and tachypnea with a respiratory rate in the 40s, and underwent placement of an endotracheal tube; details not reported.Post intubation, the patient experienced an event of bradycardia into the 30s, electrocardiogram changes; details not reported, hospital staff initiated cardiopulmonary resuscitation efforts that included four rounds epinephrine; intravenous route, dosing not reported, and one defibrillator shock due to the ventricular fibrillation.The hospital staff successfully rescued the patient, and placed him on a mechanical ventilator; brand and model not reported, with settings of synchronized intermittent mandatory ventilation (simv) mode, 26 breaths per minute, 380 milliliters tidal volume, positive end-expiratory pressure of 10 centimeters (cm) of water (h2o), 65% fio2, was administered vasopressors, sedatives, and paralytics via intravenous route; drug names, dosing, and frequencies not reported.As of (b)(6) 2021, the patient continues to be admitted to the icu, the vasopressors were discontinued, sedative and paralytic medications continue, and the patient continues to receive mechanical ventilation therapy.This reporter stated that there is no relationship between the patient experiencing a cardiopulmonary arrest, requiring mechanical ventilation, and the v60 device not transitioning into non-invasive therapy.This was a malfunction of the flow sensor.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11179887
• MDR Text Key: 227473609
• Report Number: 2031642-2021-00176
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR
• Patient Weight: 125