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

Model Number V1000

Device Problems Sticking (1597); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the ventilator was not functional due to an oxygen valve stuck closed occurrence during normal ventilation operation.The customer reported the unit was not in use on a patient therefore there was no patient involvement or harm.Upon detection of an oxygen valve stuck closed, the ventilator will alarm and continue to ventilate using an air gas source.Loss of the oxygen source can be detrimental to a patient if in use.The customer biomed technician was unable to duplicate the reported problem.The product support engineer advised the customer perform a complete performance verification before returning the device to service.The customer reported the device passed a full performance verification.There were no parts replaced.The device was returned to service.

Manufacturer Narrative

Mfr's service not requested.

• 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: 4042414
• MDR Text Key: 15814416
• Report Number: 2031642-2014-00914
• 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: Other,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/30/2014

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: 07/30/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2008
• 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