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

Model Number V60 V60PLUS VENTILATOR

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that there was a high flow without flow issue.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no harm to the patient or user.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the customer called technical support to report that there was a high flow without flow issue.A service proposal for repair was sent to the customer for approval, and the customer accepted.A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Upon arrival, the fse confirmed that the reported issue could not be duplicated.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.

Manufacturer Narrative

H10: 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.A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Upon arrival, the fse found that the reported issue was due to a user error-- per good faith effort (gfe) response, the ventilator did not get the desired target of 80l/min; however, the circuit that the customer used had a maximum target of only 60l/min.The fse confirmed that the customer has been working with the ventilator on high flow therapy (hft) mode and has not had any more issues.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: correction to the (device) problem code grid based on the customer report of high flow without flow issue.

• 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: 18169239
• MDR Text Key: 328600513
• Report Number: 2518422-2023-31117
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• 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,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 V60PLUS VENTILATOR
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/15/2024; 02/07/2024; 02/07/2024
• Supplement Dates FDA Received: 01/25/2024; 02/09/2024; 02/09/2024
• Date Device Manufactured: 10/05/2020
• 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