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

Model Number V60

Device Problems Defective Alarm (1014); Failure to Power Up (1476)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

Philips received a complaint from the customer on the v60 ventilator that the unit has a dark screen with continuous alarm at start-up even after the customer had removed the battery, indicating that the unit would not turn on.It was reported there was no patient involvement at the time the issue was discovered.The remote service engineer was unable to check the logs.Onsite service is currently pending.

Manufacturer Narrative

A field service engineer (fse) went onsite to evaluate the device.The fse confirmed the reported power issue and replaced the data acquisition (da) printed circuit board assembly (pcba), motor controller (mc) pcba, power management (pm) pcba, and power supply to repair the device.The device passed the required performance verification tests per philips standards and was returned to service.

Manufacturer Narrative

H6.Corrected: device problem code.

• 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: 18948804
• MDR Text Key: 338237128
• Report Number: 2518422-2024-14629
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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: Other
• Device Model Number: V60
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 03/26/2024
• Supplement Dates FDA Received: 03/21/2024; 03/28/2024
• Date Device Manufactured: 10/09/2020
• 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