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

Model Number V60 PLUS

Device Problems Human-Device Interface Problem (2949); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2021

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the v60 unit is switching to hft mode functions randomly.Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury was reported.

Manufacturer Narrative

Reporter phone number - (b)(6).

Manufacturer Narrative

The customer stated the problem came from the fact that the patient tube was connected and a test bag was connected to it; the v60, therefore, considered that a patient was present and therefore refused the pause mode.The international service engineer (se) was dispatched to the site.The international service engineer stated that the passage high flow therapy is correct.There was no malfunction observed on the device.The se stated that the reported problem resulted from a user error.The system met the specifications for the performed service and was returned to use.

Manufacturer Narrative

The data acquisition (da) pcba was returned for failure analysis.Visual inspection of the customer returned da board revealed no anomalies.A failure investigation (fi) technician installed the data acquisition (da) board into a fi ventilator to duplicate the reported issue of switching to htf mode functions randomly.The fi technician identified no fault found.Fi investigation could not replicate problem.Test ventilator did not switch operating modes during testing.

• 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: 13194021
• MDR Text Key: 286938546
• Report Number: 2031642-2022-00090
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 12/31/2021; 10/19/2022
• Supplement Dates FDA Received: 02/18/2022; 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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