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Adverse Event Report

BEAR MEDICAL SYSTEMS, INC. HUMIDIFIER   back to search results
Model Number VH820
Event Description

Humidifier connected to ventilator overheated, melting chamber assembly to humidifier housing. Unit turned off. No pt harm. Humidifier connected to ventilator overheated, melting the chamber assembly to the humidifier housing. Humidifier alarmed. Rn on duty checked alarm, could see no error code and pressed reset. Unit alarmed again. She notified respiratory therapist on duty to come and check unit and again pressed reset. Before therapist would arrive in unit, rn received third alarm and could smell burning and see smoke. At this point she turned unit off. Digital display on humidifier read 37 c. Rn states tubing felt cool. All 3 alarms happened within 8 min period after vent check. Rptr interviewed rn and therapist. Both state no alarms prior to incident. Unit seemed to be functioning well. Draining ventilator tubing for condensate as usual. Pt seems stable with no change in condition or therapy being administered.

 
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Brand NameHUMIDIFIER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BEAR MEDICAL SYSTEMS, INC.
riverside CA 92507
Device Event Key11866
MDR Report Key11866
Event Key7961
Report NumberMW1000979
Device Sequence Number1
Product CodeBTT
Report Source Voluntary
Report Date 03/02/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/1994
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberVH820
Was Device Available For Evaluation? Device Returned To Manufacturer
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 03/08/1994 Patient Sequence Number: 1
#TreatmentTreatment Date
1,A FIB WITH RVR, CHF, ACUTE RESP FAILURE, UNSTABLE,
2,ANGINA, POSSIBLE PNEUMONIA, R/V/MI ARDS.,

Database last updated on January 30, 2009

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