Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Disconnection (1171)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 07aug2020.
 
Event Description
The customer reported proximal line disconnect when setting up for use.The customer was unable to duplicate the issue with the test lung.The customer advised there were no significant errors in the logs.The remote service technician advised the customer to perform a full performance verification test (pvt) to help diagnose the issue.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.
 
Manufacturer Narrative
G4:04feb2021.B4:05feb2021.The customer confirmed the flow sensor was replaced and unit was checked out and returned to service.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key10382833
MDR Text Key203147314
Report Number2031642-2020-02718
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-