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

Model Number V60

Device Problem No Flow (2991)

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

Event Date 11/05/2023

Event Type  malfunction  

Manufacturer Narrative

E1 (b)(6).

Event Description

Philips received a complaint from the customer on the v60 indicating that the device is getting an "oxygen not available" alarm and "bacteria filter must be installed onto gas outlet" alarm.The unit was being used on the patient with fraction of inspired oxygen (fio2) setting at 25%.A nurse restarted up the unit and confirmed that the alarms were not duplicated, so the unit was continued to be used.However, now the oxygen not available" alarm and a check vent alarm occurred again.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.No medical intervention was provided to the patient.No delay to therapy was noted.The manufacturer's product support engineer (pse) evaluated the device and restarted up the device and confirmed that the alarms were not duplicated.He modified the fio2 setting to 21% and the unit was continued to be used while preparing a backup device.The investigation is ongoing.The device was then replaced with a backup unit.The investigation is ongoing.

Manufacturer Narrative

After further evaluation, the reported issue was not duplicated by a test run that was performed.Occurrence record of "check vent: oxygen device failed" (diagnostic code: 1111) was confirmed in the event log.Once "check vent: oxygen device failed" occurs, a v60 continues ventilating function with 21% of oxygen concentration regardless of the set value of oxygen concentration.At the same time, it generates an ¿oxygen not available" alarm.The "bacteria filter must be installed onto gas outlet" is not an alarm but what is displayed as information message at every startup of the device.A check regarding the "oxygen device failed" was performed and no abnormality was observed.A v60 calculates how much high-pressure oxygen needs to be delivered against the flow from blower motor to supply the oxygen concentration which is set as the oxygen supply method.Therefore, in case a flow which exceeds the leak compensation ability of the v60 is generated as well due to circuit leak, patient circuit being disconnected and such, "check vent: oxygen device failed" occasionally occurs.No parts replaced.The device passed the required performance verification tests per philips standards and was returned to service.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18104551
• MDR Text Key: 327773137
• Report Number: 2518422-2023-29724
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/21/2023
• Date Device Manufactured: 06/11/2019
• 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
• Patient Sex: Female