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

Model Number V60

Device Problems Device Difficult to Program or Calibrate (1496); Failure to Read Input Signal (1581); Failure to Shut Off (2939); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 30jun2020.

Event Description

The customer reported when turning on the unit, there is no air flow.When trying to turn off the unit, it responds to touch when choosing shutdown, but the screen then freezes.The customer calibrated the touchscreen and it is working, but when the customer hits the shutdown button, the unit freezes and needs to unplug from ac (alternating current) to turn the unit off.The caller advised has cooling fan speed error, auxiliary alarm supply failed, 35 (volt) supply failed, alarm light-emitting diode (led) failed and backup alarm failed error in the significant event logs.The remote manufacture service technician advised if the customer has a spare power management (pm) printed circuit board (pcb) or motor controller (mc) pcb to swap out and isolate.The customer has requested part identification for pm pcb and mc pcb.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.The customer confirmed the problem has been resolved by replacing the power management (pm) printed circuit board (pcb).

Manufacturer Narrative

G4: 15jun2020 b4: (b)(6) 2020 no parts were returned for failure investigation; therefore, the root cause at the component level could not be determined 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: 10215818
• MDR Text Key: 197645390
• Report Number: 2031642-2020-02249
• Device Sequence Number: 1
• Product Code: MNT
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1