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

Model Number V60

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

Patient Problems Apnea (1720); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/28/2021

Event Type  Death  

Manufacturer Narrative

Date of report: 10aug2021.(b)(4).

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator continued to deliver the set rate of 10 breaths per minute when the patient experienced an event of apnea, the device did not generate a low-rate alarm, and the patient experienced an outcome of death.The customer reported that the unit was in use on a patient at the time of the reported device behavior, adverse event, and patient outcome.This reporter stated that a patient of unknown age, gender, height, and weight in very poor condition with a poor prognosis; details not reported, was admitted to a hospital on an unknown date with an admitting diagnosis of chronic obstructive pulmonary disease exacerbation.Relevant medical history included chronic obstructive pulmonary disease (copd); diagnosis date not reported.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed non-invasive ventilation therapy via the respironics v60 ventilator in spontaneous / timed (s/t) mode with the low-rate alarm set to 1 breath per minute and the back-up rate set to 10 breathes per minute.The prescription, device settings, configuration, patient circuit, and patient interface were not reported.While admitted on an unknown date, the patient was receiving therapy via the v60 device, was not being continuously monitored, the patient became apneic, the v60 did not generate any audible or visual alarms, the v60 continued to deliver breaths at the set rate of 10 per minute, and the patient experienced an outcome of death.The date and cause of death were not reported.No relevant laboratory data was reported.No medical intervention was reported.

Manufacturer Narrative

During follow-up with the customer, the customer stated the intent of reporting this event was not to report a product malfunction but to inquire about future software upgrades and provided additional information about the incident.The patient was very ill and placed on a non-invasive ventilator for relief/ comfort, according to the customer.The ventilator settings were set at a backup rate of 10 and an alarm rate of 1, causing no alarms when the patient expired.There was no external/ nurse call system was connected at the time of the event.Based on the information, the patient's demise was not related to a product malfunction as the ventilator worked as intended.The customer did not request philips to evaluate the device.

Manufacturer Narrative

H11: b1: adverse event and product problem.

Manufacturer Narrative

Patient impact code updated based on previous information submitted.Further good faith efforts were attempted to gather additional information regarding device evaluation with no response from the reporter.Based upon the information provided, the device protective measures functioned as designed and appropriately.However, due to unintentional use error the low respiratory rate alarm had been overridden and defeated by the set device respiratory rate frequency.Due to this unintentional use error, the patient episode of apnea did not provide an audible or visual device alert to the clinical end user and the patient subsequently expired.Device inherently safe design risk control measures permit patients within labelled indications for use to continue spontaneous breathing while connected to the ventilator in the event of a complete cessation of flow/therapy.Additionally, the device provides visual notification via the graphic user interface to alert the clinical end user that the low respiratory rate alarm has been rendered non-functional when set below the device delivered respiratory rate frequency.No causal relationship of the device to the patient outcome has been noted, however the unintentional use error of inappropriately set alarm thresholds has been determined to be contributory to the patient outcome.Root cause has been determined as unintentional use error related to properly setting the device low respiratory rate alarms and potential contraindicated use of the v60 ventilator.

• 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: 12305088
• MDR Text Key: 265963074
• Report Number: 2031642-2021-04531
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/13/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 10/25/2021; 03/17/2022; 05/17/2022
• Supplement Dates FDA Received: 11/19/2021; 03/18/2022; 05/31/2022
• 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): Death