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

Model Number V60

Device Problems Unable to Obtain Readings (1516); Tidal Volume Fluctuations (1634)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting that the v60 ventilator was not reading the exhaled tidal volume.The device was in clinical use when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator was not reading the exhaled tidal volume.While troubleshooting, it was observed that the average air was reading at 1.4 slpm (when set to 0).The rse recommended replacing the flow sensor assembly and was provided with the part number.The investigation is ongoing.

Manufacturer Narrative

Insufficient information is available to determine the resolution of the event.The customer was provided with the parts id; however, it could not be confirmed if the customer replaced the specified parts.Multiple good faith efforts (gfe) were performed for further details regarding the event; however, no response was provided.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.

Manufacturer Narrative

The customer reported that the device was giving low end tidal volume error.It was reported that when the device was tested, when set flow as at 35 lpm, and o2 was at 100%, the actual output was 9.36 lpm.The customer also reported that the error codes observed were 120e (alarm message: low minute ventilation) and 120f (alarm message: low tidal volume).The investigation is ongoing.

• 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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17541377
• MDR Text Key: 321080890
• Report Number: 2518422-2023-19627
• 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,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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 09/06/2023
• Supplement Dates FDA Received: 09/01/2023; 09/08/2023
• Date Device Manufactured: 05/30/2018
• 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