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

Model Number V60

Device Problem Complete Loss of Power (4015)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had an ovp (over voltage protection) circuit failed malfunction.The device was in clinical use when the issue occurred.There was no patient or user harm reported.A philips remote service engineer (rse) evaluated the device with the customer and noted that the device displayed the following error codes, "1000 (cbit) vent-inop: 3.3 v supply failed, 1118 (post) 5 v supply failed, and 111b (post) check vent: 35 v supply failed.It was also reported that the device displayed an error code for mc pcba adc (motor control pcba analog to digital converter) failed and ovp circuit failed.As all the error codes were reported at the same time, the issue was determined to be an ovp circuit failure.The customer reported that the power management board was replaced, but the issue was not resolved.The customer then replaced the motor control (mc) board, and the issue was resolved.The customer confirmed that the issue involved the motor control board.The customer was provided with the part number for a replacement.

Manufacturer Narrative

H10: g - contact office address and phone number: (b)(6).

Manufacturer Narrative

Insufficient information is available to determine the resolution of the event.The customer confirmed that the issue involved the motor control board; however, it could not be confirmed if the customer replaced the part to resolve the issue.Multiple good faith efforts (gfe) were performed for further details regarding the event; however, no response was provided.No further details could be obtained regarding the event.No parts were returned for failure investigation.The complaint will be processed for closure.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.

• 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: 19061594
• MDR Text Key: 339616795
• Report Number: 2518422-2024-18070
• 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: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/18/2024
• Date Device Manufactured: 11/01/2018
• 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