MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Contamination (1120); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 11mar2021.

Event Description

The customer called into technical support (ts) reporting that the device is displaying (blower over temp alarm) error code.The device was in clinical 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.The customer reports that the air inlet filter was clean and that the circulation fan operates however the filter was very dirty to the point it could have lead to heat build up.The rse advised the customer to replace the filters and clear any dust from the unit.The rse also advised to perform pvt to see if the issue can be duplicated.

Manufacturer Narrative

G4:29mar2021.B4:06apr2021.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.Since this was an alarm the staff was unfamiliar with, the v60 ventilator was promptly changed out to another v60 ventilator.The patient did not experience any adverse effects or additional interventions due to the alarm on the v60 as therapy was not interrupted.It was also noted that after the blower's initial alarm over-temp, the v60 continued to ventilate the patient without further alarms.Another respiratory therapist staff member brought the second v60 unit to the patient's room, entered the appropriate settings and alarms on the second v60 (while the patient remained on the first v60).The mask, circuit, and filters were changed from the first v60 over to the second v60, without interrupting the niv therapy the patient was receiving.According to the diagnostic report, the timeframe between the initial alarm for "blower over temp" to "system shutdown" was only 18 minutes.It was reported that there was no troubleshooting needed to be performed, as this was an alarm not common to the end-user, traced to user error.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed that the air inlet filter was clean and that the circulation fan operates; however, the filter was very dirty to the point it could have lead to heat build-up.The customer was advised to replace the filters and clear any dust from the unit.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4:29mar2021 and b4:19apr2021.In the initial call, the hospital's biomed indicated that the air inlet filter was clean; however, the cooling fan filter was very dirty to the point that it could have lead to heat build-up.The biomed reported that the cooling fan filter was cleaned during performance verification testing (pvt).The v60 user and service manuals indicate that the cooling fan filter can collect lint and dust and, therefore, be inspected and cleaned/replaced at regular intervals to ensure proper system performance.The service guide specifies a monthly frequency for cooling fan filter inspection.Based on this information, it has been concluded that the reported failure occurred due to user error.There was no device malfunction.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11468022
• MDR Text Key: 242581300
• Report Number: 2031642-2021-00939
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 02/11/2021; 02/11/2021
• Supplement Dates FDA Received: 04/06/2021; 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER