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

Model Number V60

Device Problem Human-Device Interface Problem (2949)

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

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution/ reporter phone#: (b)(6).

Event Description

The field service engineer (fse) reported on behalf of the customer that there was a navigation ring issue.There was no patient involvement.The field service engineer (fse) determined that the front bezel needed to be replaced.The front bezel was replaced to resolve the issue.The root cause of the navigation ring failures was determined to be liquid ingress due to the variability of the assembly process.

Manufacturer Narrative

Upon further investigation, the touchscreen can be used to change settings and the device does not change settings by itself.The device will continue to function and ventilate the patient, and thus pose no risk for serious patient injury.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: 13641873
• MDR Text Key: 286947699
• Report Number: 2031642-2022-00561
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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

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: 1053613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 04/01/2022
• Date Device Manufactured: 03/22/2013
• 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