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: IMPACT INSTRUMENTATION, INC. IMPACT 73X PORTABLE VENTILATOR SYSTEM
  • 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
 

IMPACT INSTRUMENTATION, INC. IMPACT 73X PORTABLE VENTILATOR SYSTEM Back to Search Results
Model Number 73X
Device Problems Circuit Failure (1089); Transducer probe overheating (1645); Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
(b)(4) this system was returned to impact for preventative maintenance.During the evaluation of the it was determined that the pressure relief valve was operating at a level below the specified operational limits.Additionally, the check valve indicated that is was leaking, though just below the operational limits, and was replaced to prevent system failure.This system had no prior impact instrumentation, inc.Preventative maintenance performed.This system is 5 years and 10 months old.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPACT 73X PORTABLE VENTILATOR SYSTEM
Type of Device
VENTILATOR
Manufacturer (Section D)
IMPACT INSTRUMENTATION, INC.
west caldwell NJ 07006
Manufacturer Contact
roy vanzant
27 fairfield pl.
west caldwell, NJ 07006
9738821212
MDR Report Key4178527
MDR Text Key5090906
Report Number2242630-2014-00003
Device Sequence Number1
Product Code BTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051476
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number73X
Device Catalogue Number800-073X-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NONE REPORTED BY THE OPERATOR
-
-