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

Model Number V60

Device Problem Tidal Volume Fluctuations (1634)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer on the v60 indicating that the device displayed a low tidal volume alarm error.The customer ran the ventilator at the same settings using the.25" test fitting and duplicated the low tidal volume alarm.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.The device was swapped out with another ventilator, and there were not any issues with the patient.The remote service engineer (rse) informed the biomedical engineer (bme) that the alarm could be caused by settings versus the.25" test fitting and advised the bme that the test fitting was very static compared to a test lung or patient, and the low vt alarms could be expected with that setup.The rse also instructed the bme to perform a full performance verification test (pvt) and address any issues found-- if the device passed all testing, the rse advised the bme that the ventilator may be put back in service.

Manufacturer Narrative

Per a good faith effort response received, the biomedical engineer stated that the flow sensor did not pass performance verification testing, but the customer refused repair as the device was 10 years old-- no repairs were performed as the device will be retired.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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18421930
• MDR Text Key: 331674355
• Report Number: 2518422-2023-38563
• 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: 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: 12/13/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/11/2024
• Date Device Manufactured: 07/19/2013
• 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