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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY/LSZ
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CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY/LSZ Back to Search Results
Model Number 3100A
Device Problem Defective Alarm (1014)
Patient Problem No Patient Involvement (2645)
Event Date 01/08/2015
Event Type  malfunction  
Event Description
The customer reported that the ventilator low map thumbwheel switch, when set to a few cm's blow the set map, will alarm when really it shouldn't alarm until it is set above the low map.No pt involvement.
 
Manufacturer Narrative
(b)(4).The carefusion field service technician evaluated the ventilator and duplicated the reported issue.Replaced the alarm pcb and ran a performance test.Ventilator operates according to manufacturer specifications.
 
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Brand Name
CAREFUSION
Type of Device
VENTILATOR, HIGH FREQUENCY/LSZ
Manufacturer (Section D)
CAREFUSION
yorba linda CA
Manufacturer (Section G)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
wendy schumacher
7607787219
MDR Report Key4504282
MDR Text Key5444614
Report Number2021710-2015-00228
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/08/2015
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 Number3100A
Device Catalogue Number768901
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/05/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2015
Initial Date FDA Received02/06/2015
Date Device Manufactured03/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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