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 Fire (1245)
Patient Problems Burn(s) (1757); Death (1802)
Event Date 01/06/2015
Event Type  malfunction  
Event Description
The customer reported the ventilator was involved in an incident where the pt mask caught on fire during a surgical procedure where the pt got burned.The customer reported the unit was in use on pt and the pt later expired.
 
Manufacturer Narrative
Pr# (b)(4).A f/u report will be submitted once the investigation is complete.
 
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 ct.
carlsbad CA 92011
Manufacturer Contact
richa shah
3000 minuteman road
andover, MA 01810
9786594907
MDR Report Key4437473
MDR Text Key17276541
Report Number2031642-2015-00084
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age70 YR
Patient Weight64
-
-