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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST SECHRIST HYPERBARIC VENTILATOR

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SECHRIST SECHRIST HYPERBARIC VENTILATOR Back to Search Results
Model Number 500A
Event Date 04/07/2011
Event Type  Malfunction  
Event Description

Pt in hyperbaric chamber on ventilator with direct observation via resp therapist/critical care nurse and hyperbaric rn. Pt completed 1 hr and 30 minutes of 1 hr 50 minute treatment when ventilator stopped working. There was no oxygen cycling the ventilator. Treatment was stopped and pt removed from chamber and ventilated with bvm. Oxygen sats remained over 90% and to 100% with bvm and oxygen. Pt returned to unit with full exam by (b)(4).

 
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Brand NameSECHRIST HYPERBARIC VENTILATOR
Type of DeviceHYPERBARIC VENTILATOR
Manufacturer (Section D)
SECHRIST
4225 e. la palma ave.
anaheim CA 92807
MDR Report Key2057581
Report NumberMW5020232
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number500A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/08/2011 Patient Sequence Number: 1
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