MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 26march2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

Customer reports unit displays high oxygen alarm.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.Event date not specified, estimate used.

Manufacturer Narrative

Date rec¿d by mfr :11apr2019.The field service engineer (fse) confirmed reported problem of high o2 alarm.The field service engineer (fse) replaced the sensor printed circuit board assembly which resolved the complaint.The fse reported device passed all performance tests and is ready to be returned to service.A sensor printed circuit board assembly (pcba) was return for analysis.A visual inspection was performed and no evidence of damage or contamination.The returned sensor pcba installed into the failure investigation (fi) test ventilator and the fi technician attempted to duplicate the reported issue high internal oxygen alarm.The device passed all tests and the reported issue could not be duplicated.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: 8453814
• MDR Text Key: 139979203
• Report Number: 2031642-2019-01808
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1