Brand Name | AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) |
Type of Device | CARDIOPULMONARY RESUSCITATION AID KIT |
Manufacturer (Section D) |
VYAIRE MEDICAL |
26125 n. riverwoods blvd. |
mettawa IL 60045 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada v?a de la producci?n |
no. 85, parque undustrial mex |
mexicali, 21397 |
MX
21397
|
|
Manufacturer Contact |
peter
sparacio
|
26125 n. riverwoods blvd. |
mettawa, IL 60045
|
8333273284
|
|
MDR Report Key | 10752081 |
MDR Text Key | 213935141 |
Report Number | 8030673-2020-00124 |
Device Sequence Number | 1 |
Product Code |
OEV
|
UDI-Device Identifier | 10885403170249 |
UDI-Public | (01)10885403170249(10)0004040782 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/28/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) |
Device Catalogue Number | 2K8004 |
Device Lot Number | 0004040782 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/02/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |