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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105; GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC10LXO2
Device Problem Device Alarm System (1012)
Patient Problem Blood Loss (2597)
Event Type  malfunction  
Event Description
Dealer states the pc board is not allowing the alarm to function.
 
Manufacturer Narrative
Should additional information become available, a supplemental record will be filed.
 
Manufacturer Narrative
The device was evaluated by the returns department where they were unable to test to verify this complaint.
 
Event Description
Dealer states, the pc board is not allowing the alarm to function.
 
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Brand Name
PLATINUM 10 CONCEN W/SENS O2 9153642105
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4931619
MDR Text Key6028395
Report Number1031452-2015-15001
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 07/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRC10LXO2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/26/2015
Initial Date FDA Received07/22/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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