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 Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 12oct2020.
 
Event Description
It was reported to philips that the device did not alarm then there was a patient disconnect.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.
 
Manufacturer Narrative
G4:12mar2021.B4:20apr2021.It was reported to philips that the device failed to alarm when it was removed from a patient while in operation.The customer requested that a 3rd party service provider to perform device testing.Customer reported that the unit passed all testing and they were unable to duplicate the reported issue.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 Key10667807
MDR Text Key211912721
Report Number2031642-2020-03673
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 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
-
-