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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE

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SECHRIST INDUSTRIES, INC. HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 500A
Event Date 01/04/2013
Event Type  Malfunction  
Event Description

A biomedical technician for the hospital reported that during a scheduled performance maintenance test it was found that the ventilator presure did not compensate for the chamber pressure.

 
Manufacturer Narrative

The reported failure was verified and duplicated. Evaluation of the device took place by the manufacturer. The exhalation knob turns past the stop due to the knob being set at the incorrect height. This allowed the knob to slip past the stop pin. Further testing found that the maximum inhalation and exhalation times and the minimum inhalation time were out of specification. The tidal volume at 1000 is out of specification at 2. 0ata, 2. 5ata and 3. 0ata. The immediate cause of the inhalation and exhalation times and tidal volume being out of specification was a malfunctioning fluidic interface.

 
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Brand NameHYPERBARIC VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 east la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 east la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key2971114
Report Number2020676-2013-00001
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type Other,User facility
Reporter Occupation
Type of Report Initial
Report Date 02/01/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number500A
Device Catalogue Number3000
Is The Reporter A Health Professional? No
Date Manufacturer Received01/04/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/08/1978
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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