MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Intermittent Loss of Power (4016)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device froze while adjusting values and rebooted as the patient was in the process of being connected to the machine.It has been confirmed that there was no harm or injury to the patient.The device was swapped out with a different device with the same settings to continue patient monitoring.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The customer reported that this v60 ventilator was part of a field correction order (fco) where the symptom is a system reboot.This device was remediated by nova biomedical, but the fco symptoms occurred even after the remediation.Following the incident, the customer has conducted internal tests.The v60 unit passed the battery test and the customer was unable to replicate the fault.The device logs show the incident taking place.The customer has requested for a field service engineer (fse) to visit the site for investigation.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse verified that the event did occur in the 'significant event logs', which shows that the device did restart at the time the customer reported.Further investigation required, escalated to biu technical/clinical and follow up wo raised for bench repair.Resolution and disposition are pending - investigation on going.

Manufacturer Narrative

H10: manufactures bench repair evaluated the device and identified error codes 1101, ventilator restarted and 3007, source/bdsetting.Cpp in conjunction.Currently, all functional checks are passing as expected.No signs of restart encountered.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: V60 V60PLUS VENTILATOR
• 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: 17392613
• MDR Text Key: 319882253
• Report Number: 2518422-2023-15452
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• 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: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/08/2023
• Date Device Manufactured: 07/18/2019
• 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