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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting that the v60 ventilator was displaying a low minute volume alarm that could not be cleared.It was noted that they were getting low ventilation error and could not get rid of the error.Also, the exhalation was going back and fourth really fast.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) advised the customer to reset the v60 to the default settings, and then reprogram the device with the following settings (mode: s/t; ipap: 15 cmh2o; epap: 4 cmh2o).After performing the instructions provided by the rse, the customer was reporting that the v60 has stopped alarming.The system meets the specification for the performed service and is returned to use.

Manufacturer Narrative

The customer reported that the diagnostic code observed in the event log was a 120e (alarm message: low minute ventilation).The customer reported that the diagnostic code could not be duplicated, and after resetting the device back to default, the reset cleared everything.The customer then performed a performance verification test, and the device met the criteria.

• 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: 17917022
• MDR Text Key: 325447748
• Report Number: 2518422-2023-26377
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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

• Date FDA Received: 10/11/2023
• 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: 10/10/2023
• Date Device Manufactured: 08/01/2011
• 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