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: RESPIRONICS CALIFORNIA, INC 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
 

RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 12/04/2019.
 
Event Description
The customer reported a ventilator in which the oxygen concentration accuracy test failed.The manufacturer's field service engineer confirmed the reported problem.There was no patient involvement.The manufacturer's field service engineer replaced the flow sensor assembly to address and correct this reported event.
 
Manufacturer Narrative
G4: 05feb2020.B4: (b)(6) 2020.A gas delivery system (gds) assembly was returned for failure analysis.A visual inspection of the returned component was performed, no notable conditions were found.An investigation was performed and the product analysis technician reported that the root cause was isolated to a defective u1 on the air flow sensor board.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
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key9414188
MDR Text Key184504535
Report Number2031642-2019-10754
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
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-