MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. V60 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V680

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the check valve on the oxygen manifold left tank fitting was sticking when the manifold was connected to wall oxygen source pressure.The customer reported there as no patient involvement.

Manufacturer Narrative

(b)(4).A follow up report will be submitted once the investigation is complete.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786593311
• MDR Report Key: 4670959
• MDR Text Key: 5608493
• Report Number: 2031642-2015-00580
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2015

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: Other
• Device Model Number: V680
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: No
• 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