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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 23may2019.The manufacturer's field service engineer (fse) performed troubleshooting but was unable to duplicate the reported error; however, the fse did confirm the error through the device event logs.The fse replaced the central processing unit (cpu) to address the findings.The unit passed performance verification testing.

Event Description

It was reported that the unit declared an error ventilator restarted due to anomalies detected during operation.It is unknown if the device was in use at the time of the event; however, there was no patient harm reported.

Manufacturer Narrative

Date rec¿d by mfr : 17aug2019.The central processing unit (cpu) board was returned to the manufacturer for failure analysis.The cpu board revealed no signs of damage or contamination.During testing, the reported failure could not be duplicated and no failures were identified.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: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8636189
• MDR Text Key: 146061256
• Report Number: 2031642-2019-03184
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1