MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 03sep2019.

Event Description

The customer reported that the unit was auto cycling.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

Manufacturer Narrative

G4: 25sep2019, b4: 27sep2019.The field service engineer (fse) could not duplicate the complaint.Autocycling is part of the parameters that the respiratory therapist (rt) determines.The customer ran the extended self-test (est) to see if any issues popped up in diagnostic codes.The est passed.The fse was onsite and ran the est on this vent.Est passed again.The customer declined any further assistance and is satisfied with current working condition.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.

Event Description

The customer reported that the unit was auto cycling.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8957040
• MDR Text Key: 156501781
• Report Number: 2031642-2019-07846
• 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
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER