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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Date of report: 09sep2021.

Event Description

The customer reported of a volume issue in a v60 device.The patient involvement information is unknown but has been requested.There was no report of patient or user harm.The customer requested for onsite support.Further information is pending.

Manufacturer Narrative

The customer confirmed with the remote service engineer (rse) the gas delivery system (gds) need to be replaced.The (fse) also identified diagnostic error "low leak co2 risk" was failing the v60 pneumatics performance verification testing.The (rse) advised replacing the gas delivery system (gds).

Manufacturer Narrative

The device also displayed error code 1203, low leak-co2 rebreathing risk.The customer reported the device was not in clinical use at the time of the event.There was no report of patient or user harm/impact.A field service engineer was dispatched to assist the customer.The gas delivery subsystem (gds) was replaced.The device passed testing and was returned to service.The gds was returned to philips failure investigation (fi) for testing.The customer complaint was verified.Root cause was failure of airflow sensor, caused by u1 drifting out of calibration.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12446629
• MDR Text Key: 270532375
• Report Number: 2031642-2021-04883
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/11/2021
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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