MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of this report: 05apr2019.The device is unavailable for evaluation.No conclusion or root cause can be determined.

Event Description

Per medwatch mw5084692, a patient was intubated and on a ventilator.The ventilator alarm started sounding and external battery light flashing.Respiratory therapy contacted and attempted to change outlets and cords.The status of the equipment did not change.The ventilator powered down prior to being exchanged.Respiratory therapy was able to exchange the ventilator immediately after.The ventilator was in use on a patient at the time of the reported event.No patient harm was reported event date not specified; estimate used.

Manufacturer Narrative

Date of report : 08apr2019.Date rec¿d by mfr 08apr2019.Added method, result and conclusion codes.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: 8489281
• MDR Text Key: 141163736
• Report Number: 2031642-2019-02105
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1