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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Calibrate (2440)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the device alarmed for post flow sensor calibration error.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) reported to the remote service engineer (rse) that the device alarmed for post flow sensor calibration error.The bme also stated that the device has software 2.30, and the average air and o2 were reading 0.0-- once the bme turned the flow to 10, the average air went up to 240 slpm.Additionally, the 110e ("air flow sensor calibration data error") and 110f ("o2 flow sensor calibration data error") error codes were logged in the history.The rse recommended that the bme should replace the flow sensor assembly and provided the bme with the part number of the flow sensor assembly for repair.The investigation is ongoing.

Manufacturer Narrative

The biomedical engineer (bme) reported to the remote service engineer (rse) that the device alarmed for post flow sensor calibration error.The bme also stated that the device has software 2.30, and the average air and o2 were reading 0.0-- once the bme turned the flow to 10, the average air went up to 240 standard liter per minute (slpm).Additionally, the 110e ("air flow sensor calibration data error") and 110f ("o2 flow sensor calibration data error") error codes were logged in the history.The rse recommended that the bme should replace the flow sensor assembly and provided the bme with the part number of the flow sensor assembly for repair.Per good faith effort (gfe) response, the repair for this device cannot be conducted at this time due to a backorder status of a part (air & o2 flow sensor assembly) needed for correction.The material ordered aligns with the recommended repair of the reported malfunction per the service manual.When all parts become available, the repairs will be conducted.If new information is received and suggests that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

• 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: 18046756
• MDR Text Key: 327053748
• Report Number: 2518422-2023-28402
• 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: 10/03/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/27/2023
• Date Device Manufactured: 06/07/2017
• 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