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

Model Number V60

Device Problem Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 27apr2020.

Event Description

The customer reported that they made a setting change and once back at the main screen they noted that the change did not take effect.The unit was not in use on a patient.The customer verified that the navigation ring works and that was not the symptoms.The product support advised customer that the touch screen would present as spots on the touch screen not responding.The customer reported that the touch screen calibration passes and that was not the issue.The customer cannot duplicate the issue now.The product support advised customer to perform a full performance verification test (pvt) to see if the issue can be duplicated.

Manufacturer Narrative

G4: 01may2020.B4: 12may2020.The biomedical engineer said that he tested the device for over several days, no settings altered by themselves, the biomedical engineer considered the problem resolved and returned to service.The biomedical engineer chalked it up to what seems to be human error.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: 10003356
• MDR Text Key: 189301596
• Report Number: 2031642-2020-01562
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1