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

Model Number V60

Device Problems Improper Flow or Infusion (2954); Inadequate User Interface (2958)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported customer reported to nmpa #1294426582023000940 that the v60 tould not trigger the air supply and had output flow issues.Unknown if in clinical use at time of event.No reports of patient harm or injury, investigation is ongoing.

Manufacturer Narrative

H11: after further review and additional information from philips international key market contact, the allegation in this record is related to touchscreen issues.H10: philips received a complaint by the customer on the v60 indicating that there was a touchscreen fault.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.Per gfe response, it was confirmed that there was a touchscreen fault and once the touchscreen was replaced, the reported issue was resolved.The device passed required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

Manufacturer Narrative

H11: device in use: philips received a complaint by the customer on the v60 indicating that the ventilator could not trigger the air supply (there was an alarm) during ward rounds--the patient was treated with non-invasive assisted ventilation according to the doctor's advice, and the nurse found that the ventilator could not trigger the ventilation (there was an alarm).After reporting to the doctor, another non-invasive ventilator was replaced immediately, and ventilation worked normally.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.

• 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: 17409545
• MDR Text Key: 320249780
• Report Number: 2518422-2023-17218
• Device Sequence Number: 1
• Product Code: MNT
• 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,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 Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 07/17/2023; 08/27/2023
• Supplement Dates FDA Received: 08/18/2023; 09/20/2023
• 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