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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 25aug2020.
 
Event Description
It was reported to philips that the device had a patient disconnect error.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
G4:06apr2021.B4:07apr2021.A philips field service engineer (fse) was dispatched to the customer site and it was determined that the data acquisition printed circuit board assembly (da pcba) and flow sensor assembly needed to be replaced to return the device to working condition.The fse replaced the da pcba and flow sensor to resolve the reported issue.The device passed performance verification testing.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
The removed data acquisition printed circuit board assembly (da pcba) was returned to the failure investigation lab (fi).A visual inspection of the da pcba revealed no evidence of damage or contamination.The fi technician installed the da pcba into a fi ventilator to duplicate the reported issue.The customer's complaint could not be verified.No fault found.The device was reported to have been in daily routine testing, there was no patient involvement.
 
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 Key10452171
MDR Text Key204528305
Report Number2031642-2020-02949
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 foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 07/16/2021
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 NumberV60
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2020
Initial Date FDA Received08/25/2020
Supplement Dates Manufacturer Received08/07/2020
06/24/2021
Supplement Dates FDA Received04/07/2021
07/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2016
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
-
-