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

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 01sep2020.

Event Description

The customer reported that the unit was failing the oxygen flow accuracy test.A thumping sound was reported.The manufacturer's field service engineer (fse) performed remote troubleshooting.The fse advised the customer to verify their test set up and reboot the unit.The customer reported that the blower was good.The customer reported a thumping sound from the unit.A replacement flow sensor assembly was ordered.There was no patient involvement.

Manufacturer Narrative

G4: 05jan2021.B4: 06jan2021.The issue was found during preventative maintenance (pm).The customer replaced the flow sensor assembly.The device was then reported to have been repaired.No other anomalies were reported or observed.The complaint investigation has come a reasonable conclusion that the event is no longer reportable.The event is no longer reportable due to the customer having confirmed that the oxygen flow accuracy test failure and thumping sound were identified during a performance verification test (pvt) conducted during preventative maintenance (pm).There was no delay to patient therapy, and therefore the malfunction does not have the potential to result in a death or serious injury.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

G4:05jan2021 b4:(b)(6)2021 the complaint investigation has come a reasonable conclusion that the event is no longer reportable.The event is no longer reportable due to the customer having confirmed that the oxygen flow accuracy test failure and thumping sound were identified during a performance verification test (pvt) conducted during preventative maintenance (pm).There was no delay to patient therapy, and therefore the malfunction does not have the potential to result in a death or serious injury.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: 10480506
• MDR Text Key: 206315260
• Report Number: 2031642-2020-03090
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2019
• 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