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

Model Number V60

Device Problems No Audible Alarm (1019); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hypoxia (1918); Tachycardia (2095); Low Oxygen Saturation (2477)

Event Date 11/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 18dec2020.

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator stopped delivering breaths to the patient.No alarms were generated, and the patient experienced an event of increased heart rate and decreased oxygen saturation.The customer reported that the unit was in use on a patient at the time of the reported device symptom and adverse event.

Manufacturer Narrative

A philips repair bench technician evaluated the device and confirmed the issue, and was unable to duplicate the symptom.A review of the received diagnostic report (drpt) showed that multiple high tidal volume (1210), patient disconnect (1200), and high rate (1211) alarms were generated.No continuous built-in test (cbit) or power on self-test (post) error codes were generated.No parts were replaced.The device passed all performance verification tests and was placed back into use with the customer.This reporter stated that an 89 years old male patient with a weight of 58.7 kilograms and unknown height was admitted to a hospital on an unknown date with an admitting diagnosis of severe dyspnea and coronavirus (covid-19).Relevant medical history included amyotrophic lateral sclerosis; diagnostic date unknown, bi-level positive airway pressure (bipap) therapy at home since 2018.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed bipap therapy via the respironics v60 ventilator with software version 2.30 with a patient interface of respironics performax full faced mask; configuration and patient circuit not reported.Device settings included: respiratory rate 20 breaths per minute, inspiratory positive airway pressure (ipap) 15 centimeters of water (cmh2o), expiratory positive airway pressure (epap) 6 cmh2o, inspiratory time (i-time) of 0.8 seconds, rise time of 3, and fraction of inspired oxygen (fio2) of 40%.While admitted on an unknown date, the patient was prescribed orders for do not resuscitate (dnr), do not intubate (dni), and comfort measures only.While admitted on (b)(6) 2020, the patient was receiving therapy via the v60 device when the patient experienced an event of increased heart rate; values not reported, a decrease in peripheral capillary oxygen saturation (spo2); values not reported, the monitoring technician notified the registered nurse of the change in condition, the nurse then found the patient nervous and shaking his head, and the v60 was powered on, no alarms were sounding, but the blower was not delivering breaths.The nurse then removed the mask from the patient, administered manual ventilation via an ambu-bag, the v60 started delivering breaths again, but the patient was placed on another ventilator and continued ventilation therapy; brand, model, and prescription not reported.No relevant laboratory data was reported.While admitted on (b)(6) 2020, the patient experienced an event of bradycardia, pulseless electrical activity, and experienced an outcome of death.The reporter stated that the outcome was due to the patient's co-morbidities and were not associated with ventilation therapy.The cause of death was not reported.Philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause could not be determined.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11038634
• MDR Text Key: 222388284
• Report Number: 2031642-2020-04639
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 58 KG