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

Model Number V60

Device Problems Pressure Problem (3012); Insufficient Information (3190)

Patient Problems Cardiovascular Insufficiency (4445); Insufficient Information (4580)

Event Date 11/23/2021

Event Type  Injury  

Event Description

The customer called into technical support (ts) reporting that the device is displaying vent inop error when rebooted.It is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.Additional information has been requested from the customer.

Manufacturer Narrative

The bipap machine device was in use on a critically ill patient (diagnosed with covid-19 pneumonia and acute hypoxemic respiratory failure) at the time the reported issue was discovered.The device reportedly stopped working and had an error message of vent inoperable.The icu staff turned the machine off for 5 seconds and was operable after it was restarted.Approximately less than 5 minutes later, the bipap was not functional, and the patient was then transitioned to vapotherm.The temporary failure of the bipap machine was a destabilizing event, after which the patient¿s oxygen saturations were not adequately maintained by non-invasive ventilation methods.The results of abgs necessitated intubation for invasive mechanical ventilation, but he sustained hemodynamic collapse following intubation and did not survive efforts to reverse that collapse.The patient died.Results and conclusion pending completion of the investigation.

Manufacturer Narrative

H11: patient information: the v60 ventilator was in clinical and therapeutic use at the time of the event.Device clinical settings were as follows: mode s/t, ipap 14 cmh2o, epap, 10 cmh2o, respiratory rate 10 breathes per minute, trigger -3, fio2 100%.Patient circuit configuration and non-invasive interface were not reported.Patient demographics were reported as follows: male, 80 years old, weight of 112.5 kg, height 175.26 cm.The patient was noted to have been critically ill for several days with primary diagnoses of covid-19, acute hypoxemic respiratory failure, coronary artery disease, hyponatremia, and benign prostatic hyperplasia with elevated psa.While receiving therapy via the v60 ventilator at approximately 0349 on (b)(6) 2021, the device experienced an inoperative condition resulting in premature cessation of positive pressure therapy.During the event in question, a respiratory therapist was alerted to respond to the institutional intensive care unit in response to the device inoperative condition.Upon arrival, it was noted by the respiratory therapist that the patient was removed from the device and receiving supplemental oxygen via a non-rebreather mask (unspecified l/min) with acceptable saturation of peripheral oxygenation (spo2).The v60 ventilator was noted to have displayed a message upon the screen stating ventilator inoperability.The respiratory therapist powered off the v60 ventilator and approximately 5 seconds later powered the device on with noted restoration of functionality.The patient was subsequently placed back onto the v60 ventilator to resume therapy.Approximately 1 hour status-post the event, an arterial blood gas was drawn from the patient revealing severe hypoxemia.The decision was made by an institutional physician to perform advanced airway placement via endotracheal tube placement and transition to mechanical ventilation on a puritan-bennett 840 ventilator.It was additionally noted that during intubation and transition to the puritan-bennett 840 ventilator the patient experienced a desaturation of spo2 to an unspecified extent which was resolved by increasing peep from 10 cmh2o to 12 cmh2o.The institution has alleged that due to the v60 ventilator inoperative condition, the patient experienced a destabilizing event resulting in inability to adequately maintain oxygenation via non-invasive ventilatory methods.The decision to intubate and provide invasive mechanical ventilation.Status-post intubation, it was noted the patient experienced irreversible hemodynamic collapse and subsequent patient expiration.H10: the v60 ventilator was inspected and evaluated by a philips authorized service provider.A diagnostic report of the device has been retrieved and inspected, confirming the presence of a 1009 diagnostic code (high pressure regulation) triggering at the time of the event in question.The authorized service provider was unable to replicate the reported complaint, however the data acquisition printed circuit board assembly (da-pcba) was replaced as per the v60 ventilator service manual and conducted preventative maintenance on the device.The device was noted to have passed performance verification testing.Based upon the information provided, no malfunction or failure to perform to manufacturer declared specifications noted.The device was in clinical and therapeutic use at the time of the event.As per the v60 ventilator user guide, the pressure regulation high alarm is triggered when pressures exceed ventilator defined thresholds.Ventilation continues.Auto resets when the alarm condition is removed; otherwise, transitions to the ventilator inoperative state if pressure continues to rise.Based upon the information provided, the device performed as expected when detecting an exceedingly high pressure threshold by transitioning to an inoperative state in order to prevent excessive pressure delivery to the patient.

• 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: 13013568
• MDR Text Key: 283178151
• Report Number: 2031642-2021-05794
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Other
• Type of Report: Initial,Followup,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?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 02/09/2022; 02/09/2022
• Supplement Dates FDA Received: 02/08/2022; 02/09/2022
• Date Device Manufactured: 11/09/2020
• 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): Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 112 KG