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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07dec2020.

Event Description

It was reported that the ventilator kept alarming patient disconnect.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.Although requested, patient information was not provided.The customer troubleshot with technical support and advised that the circuit had been changed out, however the issue continued.The customer advised that when the ventilator was changed the same mask and circuit were used on the replacement with no issues.The customer was advised to provide what mask as being used to see if the leak settings were set correctly, to check the ventilator diagnostic report and perform a performance verification test (pvt).Upon a follow up, the customer reported that the unit was tested with the original patient settings for well over an hour without issue.The ventilator diagnostic logs were reviewed and had error code patient disconnect multiple times.The reported issue was not duplicated by the customer, the unit passed performance verification and was returned to use.

• 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: 10962250
• MDR Text Key: 220694367
• Report Number: 2031642-2020-04423
• 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
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1