MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2021

Event Type  Death  

Manufacturer Narrative

Event date: (b)(6) 2021.Report date: 19jan2021.

Event Description

It was reported to philips that the device had an unknown malfunction while in use on a patient.The device was use at the time of the event.A good faith effort was been made and it was stated that medical intervention was required.No further information was provided.

Manufacturer Narrative

G4:11feb2021.B4:19feb2021.The bipap focus is an end of life.A letter dated 25jul2014 notified customers that "non-ce markets will be discontinued on december 31, 2014".The hospital's biomedical engineer removed the device from service.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with an admitting diagnosis of coronavirus (covid-19).No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed bi-level positive airway pressure (bipap) therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2021, the patient was receiving therapy via the v60 device, the device generated over pressure condition (41), disconnect (639), hi p reg (640), and apnea (644) alarm, the patient experienced an event of respiratory distress, the patient underwent an intubation procedure; details not reported, and was administered mechanical ventilation; details not reported.No relevant laboratory data was reported.The outcome of the adverse event was not reported.Philips was not able to confirm the reported malfunction.The device is an end of life durable medical equipment whose support and service stopped up to five years after december 31, 2014.G4:12feb2021.B4:19feb2021.This patient with multiple co-morbidities; not specified, was admitted to the hospital with an admitting diagnosis of coronavirus (covid 19).While admitted on (b)(6) 2021, the patient was receiving therapy via the v60 device, the patient¿s condition changed and they experienced an event of acute respiratory distress syndrome, the device generated over pressure condition (41), disconnect (639), hi p reg (640), and apnea (644) alarm, the patient experienced an event of respiratory distress, the patient underwent an intubation procedure; details not reported, and was administered mechanical ventilation; details not reported.Post intubation on (b)(6) 2021, the patient experienced an outcome of death.This reporter stated that the device¿s behavior was due to the respiratory distress syndrome.The cause of death was not reported.The patient expired unrelated to a ventilator malfunction.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.

Manufacturer Narrative

G4: 25feb2021.B4: 25feb2021.The device in use at the time of the reported device behavior and adverse event was a bi-pap focus.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.

Manufacturer Narrative

G4:(b)(6) 2021.B4:(b)(6) 2021.H10: the reporter stated that the patient's outcome was related to there admitting diagnosis and multiple co-morbidities.There was no allegation against the bi-pap focus and the patient's outcome.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: BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11194423
• MDR Text Key: 227545346
• Report Number: 2031642-2021-00194
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2021

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/12/2021; 01/12/2021; 01/12/2021
• Supplement Dates FDA Received: 02/19/2021; 02/25/2021; 03/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Other