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

Model Number V60

Device Problems Device Alarm System (1012); Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.

Event Description

It was reported that the unit declared a "no oxygen available" error.The device was in use at the time of the event; however, there was no patient harm.It was confirmed that there was no desaturation on the patient.The manufacturer's remote service technician performed troubleshooting with the customer.The customer reported that an oxygen device failure was noted in the unit's significant event log.The customer also found there was a leak at the air inlet filter and the unit failed high pressure testing.The technician advised the customer to replace the o2 valve as a first step.If that o2 valve does not correct the issue, the customer was advised to replace the data acquisition board.

Manufacturer Narrative

G4: 10apr2020.B4: 13apr2020.The customer reported that the unit was in use on a patient during the event with no harm noted.Due to limited information provided, provision of medical intervention to prevent/preclude harm is unclear and therefore has not been ruled out.Assessment of complaint with this assumption has been considered via clinical risk review and shall be reported as serious injury.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.

Manufacturer Narrative

G4: 01apr2020.B4: 01apr2020.The customer replaced the solenoid to resolve the issue.The customer also performed maintenance and verification testing on the unit and it was returned to service.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: 9892145
• MDR Text Key: 188262421
• Report Number: 2031642-2020-01049
• 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,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• 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: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER