MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: (b)(4) 2019.International udi: (b)(4).Reporter phone number unknown.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue by reviewing the device event log.The fse replaced the central processing unit board and the issue was resolved.

Event Description

It was reported that the unit declared a "backup alarm failed" error.There was no patient involvement.The event date was not specified; estimate used.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: lisa cardenas ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8348290
• MDR Text Key: 136606821
• Report Number: 2031642-2019-00974
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2018

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: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2019
• Initial Date FDA Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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