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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/29/2021

Event Type  malfunction  

Event Description

The customer called into technical support (ts) reporting that the device is reading high tidal volumes, alarms high tidal volume and volumes are incorrect.The device was in use at the time the reported issue was discovered; however, there was no harm to the patient or user.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.Customer was experiencing issues performing the returning ventilator to use testing with the proximal pressure line disconnected alarm.Identified that the customer was not using the test orifice.Customer used the test office and the testing passed.The rse advised caller to perform a complete pvt and determine if there is anything faulty on the unit.Determined that caller has the service tool kit however is not familiar with the unit.The rse emailed caller a new service manual and advised to follow the directions to perform the pvt step by step and callback for assistance as needed.

Manufacturer Narrative

The device was swapped out with a different device to use on the patient.No medical intervention provided to the patient, nor a delay was noted.There was no harm to the patient or user.The customer called back to advise that the performance verification testing passed.

• 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: 12858462
• MDR Text Key: 285680221
• Report Number: 2031642-2021-05595
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2022
• Date Device Manufactured: 02/12/2013
• 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