Brand Name | PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 |
Type of Device | GENERATOR, OXYGEN, PORTABLE |
Manufacturer (Section D) |
INVACARE REHABILITATION EQUIPMENT CO. |
no.5 weixi road, sip |
suzhou jiangsu 21512 1 |
CH 215121 |
|
Manufacturer (Section G) |
INVACARE REHABILITATION EQUIPMENT CO. |
no.5 weixi road, sip |
|
suzhou jiangsu 21512 1 |
CH
215121
|
|
Manufacturer Contact |
kevin
guyton
|
one invacare way |
elyria, OH 44035
|
8003336900
|
|
MDR Report Key | 5697642 |
MDR Text Key | 47432113 |
Report Number | 3008262382-2016-00437 |
Device Sequence Number | 1 |
Product Code |
CAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
05/17/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/03/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | IRC5PO2 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/17/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |