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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 02/11/2024

Event Type  Injury  

Manufacturer Narrative

E: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator indicating that there was multiple check vent alarm.The device was reported to be in use at the time of the reported problem.Prior to the device being placed on the patient, the patient experienced chest tightness, fast heart rate, difficulty breathing, cyanosis of the lips, end sitting position, nasal cannula oxygen inhalation (3l/min), and finger pulse oxygen of 87%.Despite medication treatment as instructed, the patient still had difficulty breathing.At 19:15, the v60 ventilator was placed and put into use for the patient to assist with breathing using non-invasive ventilation.The v60 ventilator produced a proximal pressure sensor autozero failed alarm, preventing the use of the device.The customer reported that the patient continued to experience worsening breathing difficulties, irritability, and a continuous decrease in pulse oxygen.After 20 minutes, the customer replaced the ventilator with another ventilator, connected the tubing again, and the device underwent a quality inspection.After passing the inspection, the device was placed into use.After 10 minutes, the patients breathing difficulties gradually decreased, and the symptoms of cyanosis on the lips decreased.Finger pulse oxygen was 95%, and the patient's mood remained stable.The investigation is ongoing.

Manufacturer Narrative

In a good faith effort (gfe) response from the authorized service provider (asp) received, it was stated the proximal pressure sensor autozero failed alarm occurred during the self-check of the ventilator prior to the device being used on the patient.The asp stated that the settings, alarm thresholds, and circuit configuration of the attachments was asked but unknown.The hospital found a 3rd party to service the v60 ventilator, which was returned to normal use.No injuries were reported as a result of the device issue.A ventilator self-check was run to confirm the device function had returned to full functionality.In a gfe response from the asp received on (b)(6) 2024, it was clarified that the repair performed by the 3rd party service was the replacement of the gas delivery system (gds).The device was returned to normal use following the parts replacement.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 18885238
• MDR Text Key: 337426421
• Report Number: 2518422-2024-13432
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening