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 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

Report date: 23jun2021.The ventilator was on a patient using an ng tube with facial hair.The patient had a lot of leak per respiratory.The ventilator was swapped out and a different type of circuit was used and the customer was able to ventilate the patient.No additional patient harm was reported.

Event Description

The customer reported the ventilator kept giving patient disconnect and proximal disconnect alarms, and the unit was alarming for low tidal volume and low minute ventilation.The ventilator was on a patient using an ng tube with facial hair.The patient had a lot of leak per respiratory.The ventilator was swapped out and a different type of circuit was used, and the customer was able to ventilate the patient.No additional patient harm was reported.Once the ventilator was swapped out, it was taken to the biomedical office where it was put on a test lung to troubleshoot.The readings for tidal volume and minute ventilation were vt=126 vte=1.2.The settings for minute ventilator and tidal volume were high vt=1185 low vt=200 lo ve=3.The remote service engineer (rse) advised the customer with the following settings that the total volume alarm and the low minute ventilator alarm are both in violation and the unit should be alarming.The rse advised the total volume is dependent upon the size of the lungs, compliance, and resistance.The rse advised the customer that another test lung could perhaps provide different readings.The rse reviewed the significant event long and did not find pertinent errors.Noted the customer sees "--" for patient leak.Mask set for 1, exhalation set for dep.The customer and rse conferenced in the clinician and advised they could be seeing "--" on a test lung due to the fact the patient leak is so low.Advised the customer the disconnect alarms could have been attributed to the facial hair and the amount of leak the v60 was seeing.Advised the customer that the low minute ventilation alarm and the low tata volume alarm is due to the alarm settings.Advised the customer to complete performance verification testing to verify that the ventilator is operating within specifications.Other information is pending.

Manufacturer Narrative

Many good faith efforts were made to follow up on the resolution; however, no response was received.The resolution and disposition are unknown.

• 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: 12049472
• MDR Text Key: 257731022
• Report Number: 2031642-2021-04166
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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: 05/28/2021
• Date Manufacturer Received: 09/13/2021
• Date Device Manufactured: 11/13/2016
• 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