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

Model Number	V60
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from customer biomed reporting the v60 ventilator would not power on.The device was reported to be in clinical use.There was no report of harm or other patient impact.The device did not meet specifications for intended use and was removed from service.A philips remote service engineer (rse) evaluated the issue with the biomed engineer (bme) and confirmed the 24-volt dc (direct current) power supply as functional.The bme installed a new battery and the issue persisted.The bme requested replacement of the power management (pm) printed circuit board assembly (pcba).
Additional Manufacturer Narrative
The authorized service provider replaced the defective power management board and tested the device to ensure resolution.The device was operational and returned to service after repairs were completed.
Additional Manufacturer Narrative
A philips authorized service provider (asp) evaluated the device and confirmed a power management (pm) printed circuit board assembly (pcba) failure as the cause by testing unit with a known working pm pcba.The necessary component is on order and will be replaced once available.

• Brand Name: RESPIRONICS
• Common Device Name: 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: 18627954
• Report Number: 2518422-2024-05497
• Device Sequence Number: 8067172
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: 00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 02/13/2024; 02/29/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/19/2024; 03/04/2024
• Date Device Manufactured: 09/26/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown