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

Model Number V60

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29sep2020.

Event Description

The customer reported unknown noise.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.

Manufacturer Narrative

G4:23nov2020.B4:24nov2020.The manufacturer¿s international service technician could not confirm the reported issue.When the fio2 was set to high value the leak amount was extreme.A possible cause is that the amount of movement of the oxygen solenoid valve became large in order to maintain the supplied oxygen concentration and its operational sound echoed inside the (gas delivery system) gds mixing oxygen and air.The customer was advised to perform a preliminary check.The repair was canceled by the customer, the unit will be returned without repair performed.No product has been returned for investigation nor were diagnostic codes/error codes provided to confirm the alleged event.A device/service history review has been performed and unit worked according to specifications prior to being released.No root cause can be confirmed at this time.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: 10603504
• MDR Text Key: 214800421
• Report Number: 2031642-2020-03503
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 1076709
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER.