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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 04/15/2024

Event Type  malfunction  

Manufacturer Narrative

H10: g1 phone number (b)(6).

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator would not go into standby mode, and would not stay in standby mode.It was unknown how the issue was found.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator would not go into standby mode and would not stay in standby mode.The customer reported that the device has software 3.00, and the high flow therapy (hft) option installed.It was noted that the air inlet filter was fairly dirty.The rse advised the customer that either the flow sensor assembly or gas delivery system (gds) assembly would need to be replaced to correct issue.The rse also discussed the management of the air inlet filter.The customer acknowledged and will order preferred part.The investigation is ongoing.

Manufacturer Narrative

H10: insufficient information is available to determine the resolution of the event.Multiple good faith efforts (gfe) were performed on 01may2024, 10may2024, and 15may2024 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: 19183416
• MDR Text Key: 341062189
• Report Number: 2518422-2024-22471
• Device Sequence Number: 1
• Product Code: MNT
• 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: Health Professional
• 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: 04/15/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/23/2024
• Date Device Manufactured: 10/16/2014
• 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