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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAN-AMERICA HYPERBARICS INC PAHI HBO CHAMBER HYPERBARIC OXYGEN CHAMBER

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PAN-AMERICA HYPERBARICS INC PAHI HBO CHAMBER HYPERBARIC OXYGEN CHAMBER Back to Search Results
Event Date 12/01/2010
Event Type  Malfunction  
Event Description

Pt was treated for diabetic foot ulcer. Pt's 25th treatment with history of sinus congestion. The door latch dislodged, resulting in sudden decompression of the chamber. Pt c/o complained of light headedness and ear tenderness. Staff notified vendor about the incident and pan-america hyperbarics inc responded with a site visit within 24 hours. Pahi replaced the outer steel latch handle and ultimately replaced the entire door latch of this chamber and the other hyperbaric oxygen chamber. ======================manufacturer response for hyperbaric oxygen chamber, pahi hbo chamber======================manufacturer fixed the door.

 
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Brand NamePAHI HBO CHAMBER
Type of DeviceHYPERBARIC OXYGEN CHAMBER
Manufacturer (Section D)
PAN-AMERICA HYPERBARICS INC
525 international parkway
suite 507
richardson TX 75081
MDR Report Key2075477
Report Number2075477
Device Sequence Number1
Product CodeCBF
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/18/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/18/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2011
Event Location Hospital

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