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

Model Number V60 PLUS

Device Problem Gas Output Problem (1266)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

During use on a patient, the ventilator alarms for errors 1111 and 1208, on two separate occasions.The unit gets restarted after each event, after the second restart the treatment continues without further incidents.The new input fails with the same errors.This time the unit is restarted after each event.After the second restart the treatment continues without further incidents.Event time sn/ (b)(4).1208,11:36.42pm,10-10-2022,o2unavailable.1111,11:36.42pm,10-10-2022,cbito2devicefailed.1208,02:15.32am,10-11-2022,o2unavailable.1111,02:15.32am,10-11-2022,cbito2devicefailed.

Manufacturer Narrative

Reporting address; institution phone & reporter phone: (b)(6).

Manufacturer Narrative

The unit was checked after the reported incident and no fault was found.During follow up with the customer, it was reported that a performance verification was performed, and the device was returned to service.

• 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: 15756924
• MDR Text Key: 303573742
• Report Number: 2031642-2022-02793
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/25/2022
• Date Device Manufactured: 08/24/2020
• 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