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

Model Number V60 V60PLUS VENTILATOR

Device Problems Failure to Sense (1559); Communication or Transmission Problem (2896)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

E1: reporting address postal: (b)(6), reporting institution phone #: (b)(6) reporter phone #: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator, indicating that the high leakage and patient disconnect alarm did not work.It is unknown if the device was in use at the time of the reported problem.No patient or user harm reported.This investigation is ongoing.

Manufacturer Narrative

H10: philips received a complaint on the v60 ventilator, indicating that the device alarmed for high leakage and patient disconnect alarm did not work, and that the over voltage protection (ovp) and oxygen not available alarms occurred.On 13mar2024, the bench service engineer (bse) evaluated the device and also found that the ovp circuit failed alarm and oxygen not available alarm had occurred.The bse determined that the motor controller (mc) printed circuit board assembly (pcba) was the cause of the alarm issues.On 21mar2024, the bse confirmed replacement of the mc pcba to resolve the alarm issues.The factory settings of the ventilator were restored, and the bse completed a performance verification test (pvt) in accordance with the v60 service manual to confirm that the device had returned to full functionality.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: 18732091
• MDR Text Key: 336628621
• Report Number: 2518422-2024-08298
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Date Device Manufactured: 09/13/2017
• 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