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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that there was a proximal sensor autozero failure.The device was reported to be outside of use at the time of the reported problem.No patient harm reported.The customer informed the remote service engineer (rse) that the device gave an error code, and this was confirmed by the customer in the device diagnostic report (drpt).The rse recommended that the customer perform the following troubleshooting steps: verify the pin alignment between the solenoids and the data acquisition (da) printed circuit board assembly (pcba), replace the proximal autozero solenoids 3 and 4, and finally replace the da pcba.The rse provided the customer with the part information for the solenoids and da pcba.This investigation is ongoing.

Manufacturer Narrative

H10: multiple good faith efforts (gfe) were attempted on 19oct2023, 25oct2023, and 15nov2023 to obtain confirmation of the troubleshooting, part order, part replacement, and resolution.No response or further information was received from the customer.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: 17986136
• MDR Text Key: 326283698
• Report Number: 2518422-2023-27577
• 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: 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: 10/17/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/22/2023
• Date Device Manufactured: 02/09/2010
• 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