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

Model Number V60 V60PLUS VENTILATOR

Device Problem Obstruction of Flow (2423)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that there was a no flow regulation error message.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) called technical support to report that there was a no flow regulation error message, and while testing the device, flows were reading high.The bme attempted to replace the data acquisition (da) printed circuit board assembly (pcba), but the issue remained.The bme troubleshot the device with the remote service engineer (rse), which included: 1.Verifying that the low-pressure plug was installed into the internal leak orifice.2.Verifying that the calibration analyzer was set to measure air in stp mode.3.Verifying that the ventilator gas outlet port was unobstructed.4.Performing the air flow sensor zero calibration (software version 3.10 or later).5.Replacing the flow sensor assembly if the air flow sensor reading was not within limits as compared to the calibration analyzer.The rse suggested that the bme should replace the flow sensor assembly and provided the bme with part number of the flow sensor assembly replacement for repair.

Manufacturer Narrative

H11: per good faith effort (gfe) response received 22jan2024, the biomedical engineer (bme) confirmed that the ¿no flow regulation error message¿ and ¿flows were reading high¿ issues were related to the device failing test 7: air flow accuracy (measured air flow values out of range).Based on this information, this is not a reportable event.

• 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: 18543719
• MDR Text Key: 333253665
• Report Number: 2518422-2024-03527
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,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: Other
• 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: 01/02/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/29/2024
• Date Device Manufactured: 03/26/2018
• 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