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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

It was reported that when the customer started up the ventilator from a state of standby before use on a patient, a "check vent: backup alarm failed" alarm occurred.There was no patient involvement.

Manufacturer Narrative

The service provider (sp) inspected the device and confirmed the reported issue.The sp replaced the central processing unit (cpu) to address the reported issue.The unit was checked overall, run-in tested, cleaned, functionally tested, and no abnormality was confirmed.

Manufacturer Narrative

Upon further investigation it was reported that this event occurred outside of clinical use (testing unrelated to set up for patient use).Therefore, this complaint no longer meets reportability requirements.

• 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: 12436964
• MDR Text Key: 270315190
• Report Number: 2031642-2021-04849
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/11/2021
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/14/2021; 03/02/2022
• Supplement Dates FDA Received: 12/10/2021; 03/25/2022
• Date Device Manufactured: 02/08/2013
• 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