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

Model Number V60

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 device indicating that error codes 1113 "barometer calibration data error", 110f "o2 flow sensor calibration data error", 1107 " proximal pressure sensor calibration data error" occurred.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.

Manufacturer Narrative

Error 1006 "da pcba adc failed" also occurred.There was no patient involvement at the time the error codes were discovered as the device was not in use and was pulled from service.A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Upon arrival, the fse spoke with the biomedical engineer (bme) about the history of the device and inspected the device.The fse then let the device run and cycle normally and reviewed the information screen and event logs.The fse noticed that components were replaced recently prior his visit and discovered that the error codes in question were from august 2023.The fse was not able to recreate the error codes while testing and running the device.The error codes could not be duplicated.The fse confirmed that the device successfully passed performance verification and electrical safety testing and was returned to service.

• 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: 18751461
• MDR Text Key: 336068258
• Report Number: 2518422-2024-08945
• 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
• 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: 02/21/2024
• 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
• Date Manufacturer Received: 03/01/2024
• Date Device Manufactured: 03/02/2015
• 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