MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problems Device Alarm System (1012); Blocked Connection (2888)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

The customer called technical support (ts) reporting that the device is failing test for occlusion, not alarming or occlusion when the patient port is blocked.The customer reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.When the patient port is occluded with no patient circuit attached the vent is not giving an occlusion alarm but it does give a prox line disconnect alarm.The rse had customer restore default settings.The unit now produces an occlusion alarm when the outlet port or the patient circuit is occluded.Advised to perform a performance verification test (pvt) and address any issue found before putting back into service.Advised to have rt put in the settings they were using, to include alarm settings, and perform the alarms test per the operators manual.The customer performed factory default and was able to get the occlusion alarm.Customer was told to perform pvt test to verify unit is fully operational.Just was doing that and then started to fail the air flow test and also 60% test on the mix accuracy test.With both of these tests, the manufacturer recommendation is to replace the flow sensor assembly.The rse provided customer with part number and price for replacement flow sensor assembly.Per good faith effort response, the customer will not be repairing the device.No parts replaced nor back in service.If the decision is made to have the device evaluated and repaired a new service order will be opened and will be captured through philip's normal complaint procedure.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15114200
• MDR Text Key: 304180167
• Report Number: 2031642-2022-01968
• 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

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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/27/2022
• Date Device Manufactured: 02/28/2017
• 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