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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707; GENERATOR, OXYGEN, PORTABLE
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INVACARE FLORIDA OPERATIONS SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number TPO100B
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available a supplemental record will be filed.
 
Event Description
The provider states the consumer had the unit on vacation and a puncture mark on it.The caller states the consumer will not return his phone calls but he is positive they dropped the unit on the ground.The caller states the unit is still working, but the display screen is black.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in oracle state: portable concentrators.Lcd pcb, control panel damaged.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
The provider states the consumer had the unit on vacation and a puncture mark on it.The caller states the consumer will not return his phone calls but he is positive they dropped the unit on the ground.The caller states the unit is still working, but the display screen is black.
 
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Brand Name
SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707
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 Key5681949
MDR Text Key45999775
Report Number1031452-2016-02425
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTPO100B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received08/05/2016
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
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