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

Model Number V60

Device Problem Failure to Sense (1559)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

H10: g: phone: (b)(6).

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had an autozero failure.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had an autozero failure.The customer reported that the alarm listed solenoids 1 and 4 were not detected and had buttons for solenoid 1 and 4 greyed out.The customer reported that the device had recently had a flow sensor assembly replaced.The rse advised the customer to check the pins on the solenoids and ensure that the pins were seated correctly with the data acquisition board.The rse recommended that the customer replace the solenoids and/or data acquisition board.The customer was provided with the part number for a replacement.Investigation ongoing.

Manufacturer Narrative

Insufficient information is available to determine the resolution of the event.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, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.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: 19154686
• MDR Text Key: 340860198
• Report Number: 2518422-2024-21351
• 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

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2024
• Date Device Manufactured: 07/10/2020
• 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