MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 V60PLUS VENTILATOR

Device Problem Blocked Connection (2888)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that a "patient circuit is occluded" alarm error occurred.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.An authorized service provider (asp) was dispatched onsite to evaluate and repair the device and confirmed that there was a clamping of an internal tube giving the technical alarm of "patient circuit is occluded"-- the tube was correctly installed, and the device was tested.Following the test procedure and verification for the device, the configuration of the device was restored to the factory settings.The device passed required performance verification tests per philips standard and was returned to service.Additionally, the asp recommended that the customer should use only the accessories and consumables that are approved by philips to guarantee the correct operation of the device.

Manufacturer Narrative

E1: reporting address state: (b)(6).Reporting institution phone #: (b)(6).

Manufacturer Narrative

H10: it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.An authorized service provider (asp) was dispatched onsite to evaluate and repair the device and confirmed that there was a clamping of an internal tube giving the technical alarm of "patient circuit is occluded"-- the internal pneumatic circuit was checked, and the device was tested.The issue was confirmed.Following the test procedure and verification for the device, the configuration of the device was restored to the factory settings.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.Additionally, the asp recommended that the customer should use only the accessories and consumables that are approved by philips to guarantee the correct operation of the device.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.

• Brand Name: V60 V60PLUS VENTILATOR
• 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: 17644163
• MDR Text Key: 322207143
• Report Number: 2518422-2023-21148
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/08/2023
• Date Device Manufactured: 08/24/2020
• 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