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

Model Number V60

Device Problem Failure to Power Up (1476)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the device would not boot up.The device was outside of use at the time of the reported problem.There was no patient or user harm reported.The customer informed the remote service engineer (rse) that the device would not boot up when attempted to be powered on.Battery led was flashing yellow, and the power led was green.The screen is black, and the device is not cycling breaths.The customer attempted to troubleshoot the issue by swapping a known working user interface assembly, power supply, power management printed circuit board assembly (pcba), and motor controller pcba, but the boot up problem persisted.The customer confirmed that they had good power voltages and confirmed the software was at version 2.30.All part connections were confirmed to be seated correctly.The customer ordered a replacement central processing unit (cpu) printed circuit board assembly (pcba) as advised and it was delivered to the customer site.Completion of the repair is still pending.

Manufacturer Narrative

H10.The replacement central processing unit (cpu) printed circuit board assembly (pcba) was received and installed into the device.The customer was not able to complete a formal verification test but stated that the reported issue was resolved because the device now powered on without any issues observed.The device has since been put into storage so there is no plan to perform further testing.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened and a supplemental report will be submitted.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19177259
• MDR Text Key: 341167288
• Report Number: 2518422-2024-22243
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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
• Reporter Occupation: Biomedical Engineer
• 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 Operator: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/15/2024
• Date Device Manufactured: 10/28/2016
• 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