MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number USED V60 PLUS VENTILATOR, US

Device Problem Human-Device Interface Problem (2949)

Patient Problem Respiratory Failure (2484)

Event Date 12/22/2021

Event Type  Injury  

Event Description

(b)(6) was made aware that during clinical and therapeutic use of the v60 ventilator, a patient had disconnected themselves from the ventilator, resulting in an unanticipated change in condition requiring medical intervention, advanced airway placement via endotracheal tube, and escalated care to an intensive care unit (icu).Several weeks after the event in question, the patient was withdrawn from mechanical ventilation and subsequently expired.The v60 ventilator was in clinical and therapeutic use at the time of the event.Device settings were as follows: mode s/t, ipap 12 cmh2o, epap 6 cmh2o, respiratory rate 16 breathes per minute, fio2 100%.The patient was noted as a male, late 50's to early 60's years of age, primary diagnosis of covid-19 with hypoxemic respiratory failure.Investigation into the event and accounts provided by the institutional respiratory therapy manager state that the patient was non-compliant and had been observed removing their non-invasive interface multiple times throughout the duration of therapy.During the event in question, the patient had removed the non-invasive interface (make/model unspecified) and due to their poor clinical status declined quickly.An institutional rapid response was called, and the patient was subsequently intubated and transferred to the icu.The device was inspected by an institutional biomedical engineer.Diagnostic reports were retrieved from the device and furnished to philips.Further evaluation of the v60 ventilator and device therapy testing via a test lung for approximately 1 hour yielded no findings of malfunction or failure to perform to manufacturer declared specifications, with all alarms and functionality of the v60 ventilator confirmed.Based upon the findings within the diagnostic report and the evaluation of the v60 ventilator by the institutional biomedical engineer, no malfunction or failure to perform to manufacturer declared specifications has been noted.Based upon the information provided, the device did not cause nor contribute to the patient outcome.No allegation of cause and/or contribution has been lodged by the institution.The root cause of the patient event was due to unintentional removal of the non-invasive interface by the patient during positive pressure therapy resulting in a rapid decline in patient condition and the need for medical intervention.

Manufacturer Narrative

Based upon the information provided, the complaint record shall be reported to relevant competent authorities as a patient serious injury due to the required medical intervention, intubation, and escalation to an intensive care unit.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 13359511
• MDR Text Key: 284504616
• Report Number: 2031642-2022-00256
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Model Number: USED V60 PLUS VENTILATOR, US
• Device Catalogue Number: U1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/28/2022
• Date Device Manufactured: 10/16/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male