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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED CORP RESMED VPAP S

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RESMED CORP RESMED VPAP S Back to Search Results
Model Number RESMET VPAP S
Event Date 12/03/2010
Event Type  Injury  
Event Description

Dme equipment - resmed bi level s pap system supplied by lincare was used according to instructions - (b)(4) - for a period of 5 months. Resmed system quit working and displayed error code 1019. Pt contacted (b)(4) and was advised that error code indicated "water damage" to unit. As this unit was only operated on a level surface and never carried in travel - the source of water damage was in question. Pt was advised that this failure is the fault of the pt and the company may bill pt for repair or system. Pt followed the instructions and never deviated on the use of this system. Pt desired to know if the interior of this unit was contaminated with water. Pt is having chronic cough and severe cold issues. Pts doctor indicated cough was asthma condition and gave strong medications for the control and treatment of this condition. The development of this condition is with in the time line of the use of the moldy and fungus containing resmed equipment use by pt. Pt believes that there is a correlation in his condition and unsafe resmed system.

 
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Brand NameRESMED VPAP S
Type of DeviceVPAP
Manufacturer (Section D)
RESMED CORP
9001 spectrum center blvd
san diego CA 92123
MDR Report Key1929505
Report NumberMW5018579
Device Sequence Number1
Product CodeMNS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device MODEL NumberRESMET VPAP S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/10/2010
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 12/10/2010 Patient Sequence Number: 1
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