MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09sep2020.

Event Description

A customer reported via a user facility report that while delivering therapy to a patient, the respironics v60 ventilator made a ¿pop¿ sound, stopped working, displayed a ¿ventilator inoperative¿ error code message, and the patient experienced an event of cardiopulmonary arrest.The customer reported that the unit was in use on a patient at the time of the reported device behavior and adverse event.

Manufacturer Narrative

G4: 04nov2020.B4: 04nov2020.This was a malfunction of the pcba sensor.No parts were returned for failure investigation.Therefore, the root cause at the component level could not be determined.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: 05oct2020.B4: 06oct2020.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty pcba sensor.The fse replaced the pcba sensor.The device passed all performance assurance tests and was placed back into use with the customer.This reporter stated that a 75 years old female patient with a height of 66 inches and a weight 165 pounds, was admitted to a hospital on (b)(6) 2020 with an admitting diagnosis of respiratory failure.Relevant medical history included respiratory failure.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020 at 1535, the patient was receiving therapy via the v60 device, the patient¿s nurse was providing patient care, the device was plugged into ac power, the device made a ¿pop¿ sound, stopped working, generated a ¿ventilator inoperative¿ error code 9003 message, the patient experienced an event of cardiopulmonary arrest, hospital staff administered cardiopulmonary resuscitation efforts, the patient was resuscitated and admitted to the hospital¿s intensive care unit.No relevant laboratory data was reported.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: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10508624
• MDR Text Key: 206287493
• Report Number: 2031642-2020-03170
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Weight: 75