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

Model Number V60 V60PLUS VENTILATOR

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 02/17/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that the device had a low rate.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.The biomedical engineer (bme) called technical support to report that the device had a low rate.The bme was not in front of the device and could not perform troubleshooting.The bme requested onsite service, and the remote service engineer (rse) created an onsite work order (wo).

Manufacturer Narrative

H10: per follow-up good faith effort (gfe) response received 25mar2024, the biomedical engineer (bme) confirmed that there was actually no patient involvement at the time the issue was discovered.

Manufacturer Narrative

An authorized service provider (asp) was dispatched onsite to evaluate and repair the device.Upon arrival, the asp found that the flow sensor was out of range.The asp replaced the gas delivery system (gds) and verified that the flow sensors successfully passed tests within range per the service manual.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• 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: 18856544
• MDR Text Key: 337113796
• Report Number: 2518422-2024-12418
• Device Sequence Number: 1
• Product Code: MNT
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/25/2024
• Supplement Dates FDA Received: 03/11/2024; 03/27/2024
• Date Device Manufactured: 09/07/2011
• 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