Brand Name | RESUS, ADLT, MASK,TUBE RESV,FLTR,10' TBG |
Type of Device | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
GALEMED XIAMEN CO., LTD. |
amoy export processing zone,39 |
section 3, haijing east road |
xiamen fujian 36102 6 |
CH
361026
|
|
Manufacturer Contact |
mindy
faber
|
75 north fairway drive |
vernon hills, IL 60061
|
|
MDR Report Key | 6425640 |
MDR Text Key | 70623654 |
Report Number | 2050001-2017-00053 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K082092 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/07/2017 |
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 |
Health Professional
|
Device Catalogue Number | 2K7012 |
Device Lot Number | 160616 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/24/2017 |
Initial Date FDA Received | 03/22/2017 |
Supplement Dates Manufacturer Received | 07/16/2017
|
Supplement Dates FDA Received | 08/07/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|