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

Model Number V60 PLUS

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 04/26/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator, while in use and running 60 liters per minute (lpm), had a great amount of rain out, which appeared to be circulating into the circuit from the canister.The ventilator was being used on a patient at the time of the reported event; however, there was no patient harm reported.The therapist troubleshot the heater and exchanged the temperature probe.It was reported that the issue was addressed by the therapist turning the flow down to 45 lpm.

• 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: 11891099
• MDR Text Key: 253007111
• Report Number: 2031642-2021-03847
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• 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

• Date FDA Received: 05/26/2021
• 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
• Distributor Facility Aware Date: 04/26/2021
• Date Manufacturer Received: 04/26/2021
• Date Device Manufactured: 02/12/2015
• 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