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

Model Number V60

Device Problem Power Conditioning Problem (1474)

Patient Problem No Patient Involvement (2645)

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

The customer reported unit will not go on standby mode.The device was not in use at the time of the reported event; therefore, there was no patient involvement.Event date not specified, estimate used.

Manufacturer Narrative

Date rec'd by mfr: 29jul2019.The manufacturer¿s field service engineer (fse) explained that if the vent detects there is a possibility of a patient connected, it will not go into standby.The fse recommended if problem persists to give the unit to a biomed technician for a full performance verification test.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: 8453360
• MDR Text Key: 139979402
• Report Number: 2031642-2019-01803
• 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: 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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• 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