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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPACT INSTRUMENTATION, INC. IMPACT 73X PORTABLE VENTILATOR SYSTEM
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IMPACT INSTRUMENTATION, INC. IMPACT 73X PORTABLE VENTILATOR SYSTEM Back to Search Results
Model Number 73X
Device Problems Fail-Safe Design Failure (1222); Fail-Safe Problem (2936)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2015
Event Type  malfunction  
Event Description
(smr #(b)(4)).This system was returned for normal preventive maintenance.Pressure relief valve was not operating properly.
 
Manufacturer Narrative
During the input test for this system, it was noted that the pressure relief valve was not operating properly.The valve was activating at 258 cm h2o when the requirement was 90 to 110 cm h2o.The valve was replaced and the system retested and is now activating correctly at 101 cm h2o.
 
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Brand Name
IMPACT 73X PORTABLE VENTILATOR SYSTEM
Type of Device
VENTILATOR
Manufacturer (Section D)
IMPACT INSTRUMENTATION, INC.
.
west caldwell NJ
Manufacturer Contact
roy vanzant
27 fairfield pl.
west caldwell, NJ 07006
9738821212
MDR Report Key4752211
MDR Text Key5772035
Report Number2242630-2015-00003
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 Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2015
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2015
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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