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

Model Number V60 VENT, CHINA  OPT: NONE

Device Problem Volume Accuracy Problem (1675)

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

Event Date 02/25/2021

Event Type  malfunction  

Event Description

The customer reported that the ventilator/co2 fault.The authorized service personnel (asp) confirmed the reported problem and low tidal volume.The customer reported that the unit was not in use on a patient.The issue was found during testing.No delay was reported.The asp found that the low tidal volume was caused by the failure of the flow sensor.The flow sensor was replaced to address the reported issue.

• 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: 11506919
• MDR Text Key: 240596931
• Report Number: 2031642-2021-03029
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60 VENT, CHINA OPT: NONE
• Device Catalogue Number: 1076717
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/25/2021
• Date Device Manufactured: 02/17/2020
• 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