MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. ESPRIT VENTILATOR; VENTILATOR, CONTINUOUS

Model Number V1000

Device Problem Sticking (1597)

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

Event Type  malfunction  

Event Description

The customer reported the ventilator was alarming due to an exhalation valve stuck open.If the exhalation valve is physically stuck open creating a sustained open event, the exhalation system will be open to atmosphere and unable to provide a pressurized breath.As the device is out of warranty, the customer contacted manufacturer's product support (pse) for assistance.Pse advised the customer replace the exhalation valve to address the reported problem.

Manufacturer Narrative

Device out of warranty; no request for manufacturer's service.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer Contact: dennis daniels ; 2271 cosmos ct.; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 3719260
• MDR Text Key: 4336807
• Report Number: 2031642-2014-00224
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/07/2014

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: Health Professional
• Device Model Number: V1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1