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

Model Number V60

Device Problem Computer Software Problem (1112)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the service engineer, reporting that the v60 ventilator displayed a 100b error code (vent-inop: watchdog test failed).There was no patient involvement when the issue occurred.There was no patient or user harm reported.During troubleshooting, it was reported that when the fio2 (fraction of inspired oxygen) was set to 50%, with the device in ventilation mode and the oxygen disconnected, the device alarms for no oxygen (error code 1111 - check vent: oxygen device failed) as it should.However, when the oxygen was connected, the device becomes inoperative and displays a 100b error.If the fio2 is set to 21%, the device will run with oxygen connected, but when the fio2 is changed from 21% to 50%, the 1111 error will re-appear, then a 100b error code will alarm after a few seconds.The rse reviewed the suggested repairs for the issue.The rse suggested disconnecting the o2 solenoid valve and observing if the device operates in ventilation mode with fio2 setting at 50%, with the o2 connected.If the device operates without the 100b or 1111 error code, the customer should check the valve and replace the o2 solenoid valve.The rse then noted that if condition persisted, the gas delivery system would need to be replaced.A follow was performed with the customer, and the rse advised the customer to disconnect the o2 solenoid valve from the data acquisition (da) board, and then power the device on in ventilation mode.The customer reported that the 1111 error code was confirmed (issue documented on a separate complaint record).The rse then advised the customer to set up the device to the previous settings, and test with the o2 solenoid connected.It was reported that the 100b error code was not duplicated.No further actions were documented by the rse for the 100b error code.

• 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: 18880372
• MDR Text Key: 337377327
• Report Number: 2518422-2024-13293
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/11/2024
• Date Device Manufactured: 11/27/2017
• 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