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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSTA MESA MFG DC HT70; VENTILATOR, CONTINUOUS, FACILITY USE

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COSTA MESA MFG DC HT70; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70
Device Problem Defective Alarm (1014)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation summary: the engineer evaluated the ventilator and found that the ventilator does not alarm at power down.Ac power was connected.Unit was powered up into diagnostic mode.The input menu showed that the alarm silence button was stuck on high signal, indicating a short.The down arrow was found not to function, and alarm silence led was illuminated.The fault was isolated to the top membrane.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the ht70 ventilator down arrow key was not working and additionally found alarm silence light-emitting diode (led) would come on automatically.The ventilator was not in use on a patient at the time of the reported event. .
 
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Brand Name
HT70
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COSTA MESA MFG DC
1620 sunflower ave
costa mesa CA 92626
Manufacturer (Section G)
COSTA MESA MFG DC
1620 sunflower ave
costa mesa CA 92626
Manufacturer Contact
kelly adams
2101 faraday ave
carlsbad, CA 92008
7606035046
MDR Report Key7856456
MDR Text Key119647025
Report Number2023050-2018-00063
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10884521542266
UDI-Public10884521542266
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/07/2018
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 NumberHT70
Device Catalogue NumberHT70PM-WW-NA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Initial Date Manufacturer Received 08/21/2018
Initial Date FDA Received09/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
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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