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

Model Number V60

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/19/2021

Event Type  malfunction  

Event Description

The customer reported the unit had a check vent alarm for alarm light emitting diode (led) failure.The customer confirmed the reported failure.The remote service engineer (rse) advised replacement of the power switch overlay on the front bezel.The customer replaced the front bezel to include the power switch overlay.The unit was tested and it returned to service.The unit was not in use, and there was no patient or user harm reported.

• 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
• MDR Report Key: 11530094
• MDR Text Key: 241482847
• Report Number: 2031642-2021-03059
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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