Brand Name | ADULT VENTIMYST DUAL HEATED WIRE BREATHING SYSTEM1.6M (63") KIT 1 |
Type of Device | HEATED WIRE VENTILATOR BREATHING SYSTEM |
Manufacturer (Section D) |
FLEXICARE MEDICAL DONGGUAN LTD. |
no. b-15 xicheng ind zone 1 |
hengli town |
dongguan city, guangdong 52346 0 |
CH 523460 |
|
Manufacturer (Section G) |
FLEXICARE MEDICAL DONGGUAN LTD. |
no. b-15 xicheng ind zone 1 |
hengli town |
dongguan city, guangdong 52346 0 |
CH
523460
|
|
Manufacturer Contact |
richard
downs
|
cynon valley business park |
mountain ash, rct CF45 -4ER
|
UK
CF45 4ER
|
|
MDR Report Key | 8358109 |
MDR Text Key | 137062597 |
Report Number | 3006061749-2018-00003 |
Device Sequence Number | 1 |
Product Code |
BTT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K150900 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/21/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 038-31-252U |
Device Catalogue Number | 038-31-252U |
Device Lot Number | NOT KNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/02/2018 |
Initial Date FDA Received | 02/21/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|