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

Model Number V60

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 22apr2020.

Event Description

It was reported that while in use, the ventilator airflow ceased.The customer reported that the ventilator was under the continuous positive airway pressure (cpap) mode when a "proximal pressure line disconnect" alarm sounded.Reportedly, when a nurse checked the device, the flow had stopped running.The device then failed to start providing flow afterwards.A doctor switched the cpap mode to the spontaneous with timed backup (s/t) mode and the device was able to start providing flow.After that, the mode was returned to the cpap mode until a replacement device was able to continue providing flow.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The manufacturer¿s international service technician inspected the device and could not duplicate the reported issue.Visual inspection was performed and no abnormality was found and no error codes were found in the ventilator diagnostic logs.The service technician found that the blower needs to be replaced.

Manufacturer Narrative

G4: 15jun2020; b4: 16jun2020.The service technician reported that the reported issue was not duplicated and the reported issue could have been caused by an abnormality in the circuit side.The service technician reported the blower was replaced as part of periodic maintenance.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.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: 18jun2020 b4: 18jun2020 b5: the patient was not placed on an alternate ventilator.The doctor was able to change the mode on the ventilator and able to start providing flow to the patient.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: 9988856
• MDR Text Key: 188819226
• Report Number: 2031642-2020-01497
• 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: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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: 04/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.