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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Power Up (1476)

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

Event Date 04/12/2024

Event Type  malfunction  

Manufacturer Narrative

G1: contact office phone: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator indicating that the device would not power on.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.The customer informed the remote service engineer (rse) that they confirmed the power supply was supplying 24 volts direct current (dc) to the power management (pm) printed circuit board assembly (pcba).The customer requested a warranty replacement of the pm pcba.This investigation is ongoing.

Manufacturer Narrative

H10: a field service engineer (fse) went to the customer site on (b)(6) 2024 and evaluated the device.The fse verified that the device would not power on.The fse replaced the power management (pm) printed circuit board assembly (pcba) and the fse then successfully completed and passed performance verification testing.The device was returned to use.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: 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: 19135425
• MDR Text Key: 341046296
• Report Number: 2518422-2024-20723
• 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,User Facility
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Date Device Manufactured: 03/08/2013
• 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