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

Model Number V60 V60PLUS VENTILATOR

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator, indicating that error codes barometer calibration data error, o2 flow sensor calibration data error, air flow sensor calibration data error, and proximal pressure sensor calibration data error appeared, indicating an spi bus failure.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.The field service engineer (fse) found the error codes upon arriving at the customer site and evaluating the device.This investigation is ongoing.

Manufacturer Narrative

H10: a field service engineer (fse) went to the customer site on 26mar2024 and attempted to resolve the issue by replacing the gas delivery system (gds).It was found that the reported issue continued despite the gds replacement, so the fse has determined that additional parts are required to resolve the device issue.The investigation is ongoing.

Manufacturer Narrative

H10: a field service engineer (fse) went to the customer site on 09apr2024 and replaced the motor controller (mc) printed circuit board assembly (pcba), but was returned to the customer with limited restriction. confirmation of the resolution of the spi bus failure is pending.The investigation is ongoing.

Manufacturer Narrative

H10: on 22apr2024, the field service engineer (fse) went to the customer site and completed a full performance verification test (pvt) and the device passed all the included tests according to the service manual which confirmed that the motor controller (mc) printed circuit board assembly (pcba) replacement resolved the issue.The device was returned to service without restrictions.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: 18770899
• MDR Text Key: 336136857
• Report Number: 2518422-2024-09502
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/26/2024; 04/09/2024; 04/22/2024
• Supplement Dates FDA Received: 04/02/2024; 04/10/2024; 05/01/2024
• Date Device Manufactured: 09/18/2014
• 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