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

Model Number V60

Device Problems Inadequate User Interface (2958); Audible Prompt/Feedback Problem (4020)

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

Event Date 08/12/2021

Event Type  malfunction  

Event Description

The customer reported they can't reset the alarms on this device when you press the reset button.The customer cannot reset the alarms on the unit and it has a yellow auto reset alert which cannot reset it or get rid of the information.The customer claims they are unable to clear the information messages.The remote service engineer (rse) recommended trying to calibrate the touchscreen, but the unit is on a patient.He mentioned the unit is operating fine, except he cannot clear the information lines.He wanted a technician on site to solve the issue.The device was in use.No patient or user harm was reported.

Manufacturer Narrative

H10: onsite service was scheduled in (b)(3) 2021 but got cancelled due to unknown reason.Then multiple attempts were made to retrieve device repair or diagnostic information but yielded no response from the customer.However, in (b)(3) 2022, a new case in service max was opened for touchscreen calibration issue.The field service engineer (fse) confirmed the issue, replaced the touchscreen, and tested the unit for performance verification.The unit passed performance verification tests successfully and returned to use.H11: device problem corrected to inadequate user interface.

• 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: 12451067
• MDR Text Key: 270791376
• Report Number: 2031642-2021-04886
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• 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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/12/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/15/2022
• 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