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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP. PREFILLED HUMIDIFIER   back to search results
Model Number 2D0803
Event Date 06/12/2002
Event Type  Malfunction  
Event Description

Account states confidential occurrence report was filed on 6/02 and states bubble humidifier not operating at 5 pm. Patient's spo2 was low. Removed bubble humidifier, patient's spo2 increased. Customer stated that patient experienced respiratory distress.

 
Manufacturer Narrative

Information has been forwarded to the manufacturing facility. Results are pending the receipt of the sample. A follow-up report will be filed.

 
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Brand NamePREFILLED HUMIDIFIER
Type of DeviceHUMIDIFIER
Baseline Brand NamePREFILLED HUMIDIFIER
Baseline Generic NameHUMIDIFIER
Baseline Catalogue Number2D0803
Baseline Model Number2D0803
Baseline Device FamilyHUMIDIFICATION
Baseline Device 510(K) NumberK760584
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed10/15/1976
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORP.
1430 waukegan road
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP.
1430 waukegan road
mcgaw park IL 60085
Manufacturer Contact
patricia shapre-gregg
1430 waukegan road
mcgaw park , IL 60085
(847) 578 -4148
Device Event Key394122
MDR Report Key405116
Event Key382903
Report Number1423507-2002-00099
Device Sequence Number1
Product CodeBTT
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/12/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2002
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL Number2D0803
Device Catalogue Number2D0803
Device LOT Number2C074
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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