MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problems Device Alarm System (1012); Self-Activation or Keying (1557); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29apr2020.

Event Description

The customer reported that the ventilator shutdown and restarted without annunciating an alarm.The ventilator was being used on a patient at the time of the reported event, however, there was no patient harm.The patient's information could not be disclosed.Technical support provided remote assistance to the customer.The customer reported the occurrence of diagnostic codes related to safety valve open alarm, and various combinations of volt failures and power fail failures.Technical support advised the customer to replace the power supply.

Manufacturer Narrative

G4: 29apr2020.B4: 07may2020.There was no report of medical intervention required as a result of this event.The customer reported that replacing the power supply resolved the problem.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: 10012168
• MDR Text Key: 189593903
• Report Number: 2031642-2020-01591
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER